Systems and methods for improved health care compliance

ABSTRACT

According to some embodiments, systems, apparatus, methods, and articles of manufacture may provide for improved health care compliance. Embodiments may comprise, for example, identifying an occurrence of an event associated with the taking of a substance by a patient, determining output information associated with a game, and providing the output information to the patient. Some embodiments may comprise receiving a code associated with a patient, wherein the code includes encoded information that is indicative of an occurrence of an event associated with the taking of a substance by a patient, decoding the code to determine the information, determining whether the occurrence of the event is compliant with a condition associated with the taking of the substance, and providing, in the case that compliance with the condition is determined, one or more rewards to the patient.

CROSS-REFERENCE TO RELATED CORRESPONDING APPLICATIONS

This application is a continuation-in-part that claims priority andbenefit under 35 U.S.C. §120 to commonly owned, co-pending U.S. patentapplication Ser. No. 10/835,422 entitled “METHOD AND APPARATUS FOROUTPUTTING A RESULT OF A GAME VIA A CONTAINER” filed Apr. 29, 2004,which is a continuation-in-part of U.S. patent application Ser. No.09/165,089 entitled “METHOD AND APPARATUS FOR DOCUMENTING CAP REMOVALDATA” filed Oct. 1, 1998, which issued as U.S. Pat. No. 6,751,730 onJun. 15, 2004, which is a continuation-in-part of U.S. patentapplication Ser. No. 08/677,544 entitled “REMOTE AUDITING OF COMPUTERGENERATED OUTCOMES AND AUTHENTICATED BILLING AND ACCESS CONTROL SYSTEMUSING CRYPTOGRAPHIC AND OTHER PROTOCOLS” filed Aug. 8, 1996, whichissued as U.S. Pat. No. 5,970,143 on Oct. 19, 1999, which is acontinuation-in-part of U.S. patent application Ser. No. 08/561,668 ofthe same title, which issued as U.S. Pat. No. 5,768,382 on Jun. 16,1998; and is further a continuation-in-part of commonly owned,co-pending U.S. application Ser. No. 08/628,920 entitled “METHOD ANDSYSTEM FOR SECURE MEASUREMENT CERTIFICATION” filed Apr. 8, 1996, whichissued as U.S. Pat. No. 5,828,751 on Oct. 27, 1998, the entirety of eachof which is incorporated by reference herein.

BACKGROUND OF THE INVENTION

A major problem facing the health care industry today is the difficultyof enforcing patient compliance with prescription and health careregimens and therapies. All too often, patients ignore the directionsassociated with their prescriptions, consuming more or fewer pills thanrecommended by their doctor. Many patients simply forget to take themedication for one or more days, resulting in a lengthened healingprocess. Adherence to prescriptions for the treatment of asymptomaticconditions is particularly troublesome. Without being reminded of thelong-term benefits of a treatment, for example, patients may stop takinga medication when no immediate benefit is apparent (e.g., decreased painor remediation of another obvious symptom).

In some cases not taking pills according to a precise schedule canresult in complications requiring expensive hospital stays or increasedtime consulting with a physician. Patients taking lipid-loweringmedications (e.g., to lower cholesterol) may, for example, experience“excess morbidity and mortality” due to noncompliance with prescriptionregimens. Jacobsen, Terry A., M.D., “The Forgotten Risk Factor:Noncompliance With Lipid-Lowering Therapy”, Medscape® Cardiology,www.medscape.com/viewarticle/496144, posted Dec. 22, 2004, at pg. 7.

Indeed, recent studies have shown that as little as forty to fiftypercent (40-50%) of patients taking 3-hydroxymethylglutaryl-coenzymeinhibitors (“statins”; e.g., Lipitor®) to lower cholesterol wereadhering to their prescriptions after just six (6) months. See, Benner,Joshua S, et al., “Association between short-term effectiveness ofstatins and long-term adherence to lipid-lowering therapy”, Am JHealth-Syst Pharm—Vol 62, Jul. 15, 2005. The additional costs due tosuch noncompliance are passed on to health care providers and insurers.Estimates are that such costs may be in excess of one hundred billiondollars ($100 billion) per year. Jacobsen, at pg. 1.

Efforts to promote increased compliance with health care prescriptionsand therapies include “[u]sing a warm and caring tone featuring morepositive than negative words,” reducing the complexity of treatmentregimens, following up with patients that miss appointments, providinge-mail reminders to patients, increasing patient education, andproviding reminder, cognitive, and/or self-monitoring aids. Jacobsen, atpg. 6. Such basic tactics have, however, “proved to be complex, laborintensive, and of unreliable effectiveness.” Id., at pg. 5. Moreadvanced approaches and methods have also been presented.

One such approach to solving the problem of patient compliance has beenthe development of modified pill containers that automatically dispensethe correct number of pills. U.S. Pat. No. 5,641,091 to Daneshvardescribes a medication-dispensing device that allows a patient toreceive his medication on a regular basis. A series of small spaces arearranged in one or more electrically powered rotating trays to allow aproper dose via a window. While this approach makes it easier for aconscientious patient to follow his prescription, forgetful patients maysimply let pills “build up” rather than consuming them. Additionally,such devices contain many moving parts that are subject to malfunctionand wear. Malfunctions could result in legal liability if the patientwas provided access to fewer pills than required by his prescription.

A similar dispensing device is described in U.S. Pat. No. 5,472,113 toShaw. The automatic pill-dispensing device of Shaw has cartridgesrotated via an electric motor, electromagnetic clutches, a rotatableshaft, and gears. As with the Daneshvar device, there is no way for aremote third party to know whether or not the device is operatingproperly and whether the patient is in fact complying with hisprescription.

Because third parties such as hospitals and insurance companies wouldlike to have access to patient prescription compliance data, otherdevices have been created to store data such as how often a pillcontainer has been opened or the time and date that it was opened. U.S.Pat. No. 5,016,172 to Dessertine and U.S. Pat. No. 4,939,705 to Hamiltonet al. both describe such an apparatus. These devices, however, eitherrequire the user to physically deliver the apparatus to the interestedthird party for data retrieval and verification, or require that thedevice have a modem for online connection to the third party. Physicaldelivery is time consuming and potentially costly for the user, while anonline connection requires expensive hardware and greater sophisticationon the part of the user.

A need therefore exists for systems, apparatus, methods, and articles ofmanufacture that address these and other deficiencies of the prior art.A need exists, for example, for securely measuring, reporting, andtracking patient compliance in an off-line environment. A need alsoexists for facilitating improved patient compliance with health careregimens.

BRIEF DESCRIPTION OF THE DRAWINGS

An understanding of embodiments described herein and many of theattendant advantages thereof may be readily obtained by reference to thefollowing detailed description when considered with the accompanyingdrawings, wherein:

FIG. 1 is a block diagram of a system according to some embodiments;

FIG. 2 is a flow diagram of a method according to some embodiments;

FIG. 3 is a block diagram of a compliance module according to someembodiments;

FIG. 4A, FIG. 4B, and FIG. 4C are block diagrams of data tablesaccording to some embodiments;

FIG. 5A is a perspective diagram of a compliance module according tosome embodiments;

FIG. 5B is a plan view of a compliance module according to someembodiments;

FIG. 6 is a perspective cross-sectional diagram of a system according tosome embodiments;

FIG. 7 is a plan view of a compliance module according to someembodiments;

FIG. 8 is a flow diagram of a method according to some embodiments;

FIG. 9 is a block diagram of a controller according to some embodiments;and

FIG. 10A, FIG. 10B, and FIG. 10C are block diagrams of data tablesaccording to some embodiments.

DETAILED DESCRIPTION

Some embodiments described herein generally relate to medicinecontainers, medicine applicators, medicine dispensers, medicalequipment, prescription medications, health care regimens or therapies,and methods for improving compliance with prescriptions and health careregimens or therapies. More particularly, some embodiments relate tosystems and methods for documenting and authenticating patientcompliance with health care regimens, and some embodiments facilitateimprovement of patient compliance.

TERMS AND DEFINITIONS

Some embodiments described herein are associated with a “patient”. Asused herein, the term “patient” may generally refer to any individual,entity, or other being associated with a prescription, therapy, or otherhealth care regimen. Patients may, for example, be persons seekingand/or obtaining preventative, therapeutic, and/or remedial health caretreatment.

As used herein, the terms “prescription”, “therapy”, “regimen”, and“health care regimen” may be used interchangeably and may generallyrefer to any plan, strategy, requirement, treatment, and/or othercondition, procedure, or act associated with the health of a patient.Prescriptions may be oral and/or written by a health care professional,for example, and filled by the patient to obtain medications, pills,vitamins, dietary supplements, and/or other health-related devices,objects, or substances.

As used herein, the terms “substance” may generally refer to anyquantity or amount of a health-related material that may be depleted,expended, and/or otherwise utilized via the effectuation of aprescription, therapy, or regimen. Examples of some such substances mayinclude, but are not limited to, pills, liquid medications, foods,drinks, ointments, patch-applied medications, inhalants, test strips,and batteries for health care devices. According to some embodiments,the “taking” of a substance may refer to the ingestion (e.g., by apatient) of a pill or medication, the application of a medicated patch,and/or the depletion of a medication or battery (or other energy source)associated with a medical, treatment, therapeutic, and/or exercisedevice.

In addition, some embodiments herein are associated with “compliance” or“adherence” to, or “acceptance” of, a prescription, therapy, or otherhealth care regimen. As used herein, the terms “compliance”,“adherence”, and “acceptance” may be used interchangeably to refer to anextent to which a patient's actions coincide with those actionsspecified by and/or associated with the prescription, therapy, and/orother health care regimen. In some embodiments, compliance may be adichotomous or Boolean value (e.g., true or false; compliant ornoncompliant), while in other embodiments compliance may comprise acontinuum. Different patients may, for example, be more or lesscompliant than others. Patients may also or alternatively be groupedaccording to one or more compliance variables. The percentage of timethat a patient takes the appropriate doses and/or the frequency ormagnitude of compliance with dosage schedules may, for example, beutilized to develop or define ranges of values within which patients maybe grouped or classified (i.e., in terms of compliance).

Some embodiments described herein are associated with a “user device” ora “network device”. As used herein, the terms “user device” and “networkdevice” may be used interchangeably and may generally refer to anydevice that can communicate via a network. Examples of user or networkdevices include a Personal Computer (PC), a workstation, a server, aprinter, a scanner, a facsimile machine, a copier, a Personal DigitalAssistant (PDA), a storage device (e.g., a disk drive), a hub, a router,a switch, and a modem, a video game console, or a wireless phone. Userand network devices may comprise one or more communication or networkcomponents.

As used herein, the term “network component” may refer to a user ornetwork device, or a component, piece, portion, or combination of useror network devices. Examples of network components may include a StaticRandom Access Memory (SRAM) device or module, a network processor, and anetwork communication path, connection, port, or cable.

In addition, some embodiments are associated with a “network” or a“communication network”. As used herein, the terms “network” and“communication network” may be used interchangeably and may refer to anyobject, entity, component, device, and/or any combination thereof thatpermits, facilitates, and/or otherwise contributes to or is associatedwith the transmission of messages, packets, signals, and/or other formsof information between and/or within one or more network devices.Networks may be or include a plurality of interconnected networkdevices. In some embodiments, networks may be hard-wired, wireless,virtual, neural, and/or any other configuration of type that is orbecomes known. Communication networks may include, for example, one ormore networks configured to operate in accordance with the Fast EthernetLAN transmission standard 802.3-2002® published by the Institute ofElectrical and Electronics Engineers (IEEE). In some embodiments, anetwork may include one or more wired and/or wireless networks operatedin accordance with any communication standard or protocol that is orbecomes known or practicable.

As used herein, the terms “information” and “data” may be usedinterchangeably and may refer to any data, text, voice, video, image,message, bit, packet, pulse, tone, waveform, and/or other type orconfiguration of signal and/or information. Information may compriseinformation packets transmitted, for example, in accordance with theInternet Protocol Version 6 (IPv6) standard as defined by “InternetProtocol Version 6 (IPv6) Specification” RFC 1883, published by theInternet Engineering Task Force (IETF), Network Working Group, S.Deering et al. (December 1995). Information may, according to someembodiments, be compressed, encoded, encrypted, and/or otherwisepackaged or manipulated in accordance with any method that is or becomesknown or practicable.

In addition, some embodiments described herein are associated with an“indication”. As used herein, the term “indication” may be used to referto any indicia and/or other information indicative of or associated witha subject, item, entity, and/or other object and/or idea. As usedherein, the phrases “information indicative of” and “indicia” may beused to refer to any information that represents, describes, and/or isotherwise associated with a related entity, subject, or object. Indiciaof information may include, for example, a code, a reference, a link, asignal, an identifier, and/or any combination thereof and/or any otherinformative representation associated with the information. In someembodiments, indicia of information (or indicative of the information)may be or include the information itself and/or any portion or componentof the information. In some embodiments, an indication may include arequest, a solicitation, a broadcast, and/or any other form ofinformation gathering and/or dissemination.

System Architecture

Referring first to FIG. 1, a block diagram of a system 100 according tosome embodiments is shown. The various system described herein aredepicted for use in explanation, but not limitation, of describedembodiments. Different types, layouts, quantities, and configurations ofsystems described herein may be used without deviating from the scope ofsome embodiments.

The system 100 may comprise and/or be associated with, for example, auser 102, a compliance module 110, a user device 140, a controller 150,and/or a network 180. In some embodiments, the compliance module 120 maybe configured to identify, detect, measure, determine, and/or encodeindications of health care-related events associated with the user 102.The compliance module 110 may, for example, detect pill bottle capremovals, movements of a pill bottle, dispensing of a liquid,application of a medicated patch, use of a therapeutic and/or exercisedevice, removal of a pill from a blister pack, and/or otherprescription, therapy, and/or health care regimen-related events. Thecompliance module 110 may also or alternatively, according to someembodiments, be configured to provide game-related information to theuser 102. The user 102 may be motivated to take a medication and/or tomore closely adhere to a regimen, for example, by receiving game-related(and/or other motivational) information via the compliance module 110.

In some embodiments, the event data associated with the user 102 may beencoded and/or encrypted by the compliance module 110 and a resultingcode and/or information may be provided to the user 102. The user 102may then, for example, utilize the user device 140 to communicate thecode or information (e.g., encoded information indicative of the healthcare-related event) to the controller 150 (e.g., via the network 180).The user device 140 may, according to some embodiments, be any type orconfiguration of network device that is or becomes known or practicable.The user device 140 may, for example, comprise a telephone (e.g., wiredor wireless) and/or other communication device associated with the user102.

The controller 150 may, according to some embodiments, utilize theencoded and/or encrypted information to determine if the user 102 iscompliant with a prescription, therapy, and/or other health careregimen. The user 102 may, for example, be a patient, and/or thecontroller 150 may be owned, operated by, and/or otherwise associatedwith a health care provider, an insurance carrier, an employer, and/oranother entity (e.g., a government agency or health department). Thecontroller 150 may also or alternatively receive game-relatedinformation from the user 102 (e.g., provided to the user 102 by thecompliance module 110). The controller 150 may, for example, utilizeeither or both of the compliance or game-related information, to provideone or more rewards to the user 102. According to some embodiments, thecompliance module 110 may also or alternatively be in communication withthe controller 150 (e.g., to provide a code and/or compliance-indicativeinformation, and/or to receive information such as prescriptioninformation or software or firmware updates).

In some embodiments, the compliance module 110 may include elements(such as electronic elements) incorporated within the cap of aprescription medication, food, or drink container, although it couldalso or alternatively take the form of an add-on module coupled orattached to either the container cap or the container itself. Thecompliance module 110 may be used in conjunction with a pill-dispensingdevice that is operated to vend pills. A system capable of holding aplurality of prescriptions could also incorporate the functionality ofthe compliance module 110. In some embodiments, the compliance module110 may be or include a device that does not dispense or contain aprescription and/or other substances. The compliance module 110 may, forexample, comprise a pressure-sensitive pad upon which medicinecontainers are placed or a medical identification bracelet and/or otherdevice capable of electronically detecting or sensing healthcare-related substances, containers, or other associated apparatus.According to some embodiments, the compliance module 110 may compriseand/or be coupled to an exercise device (such as a treadmill) to monitora patient's exercise routines and/or health-related metrics (e.g., heartrate).

In operation according to some embodiments, a user 102 may employ thecompliance module 110 to measure and document the number of times thatan openable or reclosable cap, lid, or other similar dispensing coveringis removed from an associated substance container. The container may beequipped, for example, with a detector that generates a first electricalsignal in response to the opening of the dispensing covering and also oralternatively a second electrical signal in response to the reclosing.

In accessing the container by removing or replacing the cap, the user102 may cause cap removal data to be generated and the data may bestored as a numeric value (e.g., via the compliance module 110 and/orcomponents thereof). This cap removal data may be (or be indicative of)the total number of times that the cap is removed in a given timeperiod, the number of days in which the cap is removed more than once,the number of days in which the cap is not removed, the average numberof removals per day, etc. It should be noted that the same measures mayapply equally to cap replacement data which is similar to cap removaldata in that both indicate the number of times that a container isaccessed. In addition to recording the quantity of removals, compliancemodule 110 may store chronographic data regarding the timing of theremovals. Such chronographic data may include the date/time of eachremoval, the average time of day of all removals over a particularperiod, the average number of hours between each removal, etc. Thecompliance module 110 may receive the cap removal data from cap removalsensors, and may encode the data, thereby generating encoded cap removaldata. In some embodiments, the encoded cap removal data may comprise anencoded version of the cap removal data, while in other embodiments, itmay additionally incorporate a user identifier, drug identifying data, acap identifier, an insurance policy identifier and/or other pertinentinformation such as biometric data or a timestamp.

In some embodiments, the compliance module 110 may display a code orinformation to the user 102. The code or information may, for example,be associated with game output provided as an incentive to facilitateimproved compliance with a prescription and/or may comprise dataindicative of one or more prescription-related events (e.g., capremovals and/or other medication or health care-related events). Suchinformation and/or encoded data may take any form that is or becomespracticable, such as a series of numeric digits, symbols, oralphanumeric characters/digits. For example, the user 102 may view aten-digit number representing the encoded data and enter these digitsinto an input device associated with the user device 140. The inputdevice may, for example, comprise a keypad of a telephone user device140 that the user 102 may utilize to communicate via the network 180(such as a Public Switched Telephone Network (PSTN)) with andInteractive Voice Response Unit (IVRU) associated with the controller150. The user 102 may also or alternatively read out the digits of theencoded data to a human operator or otherwise communicate the data tothe controller 150.

The controller 150 may, according to some embodiments, decode thereceived encoded data and store the resulting decoded information. Insome embodiments, an entity (such as a health care-related entity) mayemploy the controller 150 to determine and authenticate healthcare-related actions taken by the user 102. The number of times that theuser 102 removes the cap of a pill bottle, for example, may bedetermined via the encoded information, thereby providing greaterassurance that the user 102 has consumed a prescribed medication. Suchcompliance data may be used to lower insurance premiums in much the sameway that motorists are rewarded with lower car insurance premiums forwearing safety belts.

The controller 150 may also or alternatively decode and/or receive theinformation to determine actions associated with one or more games.Patients determined to meet certain compliance criteria, for example,may be entered into sweepstakes, lotteries, and/or other games of chanceor skill. The controller 150 may, for example, provide a compliantpatient with one or more lottery tickets or numbers as a reward forattaining compliance. In some embodiments, such as in the case that theinformation generated by the compliance module 110 comprisesgame-related information (such as game output intended to promoteimproved compliance), the controller 150 may analyze and/or otherwiseprocess the information to determine one or more actions or resultsassociated with a game. A patient may, for example, provide thecontroller 150 with information (which may be encoded) that indicatesthat the patient has won a game or prize. In some embodiments, thecontroller 150 may award and/or provide a prize to the patient.According to some embodiments, compliance and/or game information frommultiple patients may be compared. Patients belonging to and/or assignedto certain groups (e.g., members of the same health insurance group,members of the same company, and/or residents of the same assistedliving facility) may be ranked, for example, to determine which patientsshould be awarded prizes and/or benefits (e.g., based on complianceand/or game results).

Compliance Module Method

Referring now to FIG. 2, a flow diagram of a method 200 according tosome embodiments is shown. In some embodiments, the method 200 may beperformed and/or implemented by and/or otherwise associated with thecompliance module 120 described in conjunction with FIG. 1. The flowdiagrams described herein do not necessarily imply a fixed order to theactions, and embodiments may be performed in any order that ispracticable. Note that any of the methods described herein may beperformed by hardware, software (including microcode), firmware, or anycombination thereof. For example, a storage medium may store thereoninstructions that when executed by a machine result in performanceaccording to any of the embodiments described herein.

According to some embodiments, the method 200 may begin by identifyingan occurrence of an event associated with the taking of a substance by apatient, at 202. The compliance module 120 may, for example, accumulateand/or store data indicating that the cap of a container has beenremoved (e.g., the cap of a prescription medication bottle or a lid to adietary supplement container). In some embodiments, such data may bereceived via signals from a sensor such as a switch that is physicallyengaged (and/or a circuit that is otherwise opened or closed) when thecontainer cap is removed or replaced. Sensors may generate data foreither or both of removals and replacements. According to someembodiments, this data may be stored in one or more data tables as aredescribed in more detail elsewhere herein. In some embodiments, dataregarding every cap removal and/or other event may be stored, althoughdata could of course be selectively stored if memory limitations are aconstraint. For example, every fifth cap removal and/or other event maybe stored and/or every cap removal and/or event occurring during certainpre-defined time periods (e.g., between the hours of 2:00 PM and 6:00PM) may be stored.

According to some embodiments, other event occurrences may also oralternatively be identified, detected, and/or otherwise determined. Inthe case that a prescription medication and/or other substance issecured inside of a blister pack, for example, an event may be indicatedby the breaking of a seal to remove one or more units of the substance.In some embodiments, the removal of an adhesive backing cover of amedicated patch (such as a Nicotrol® or NicoDerm® nicotine patch) mayalso or alternatively define such an event. According to someembodiments, the actual usage, ingestion, and/or other application ofthe substance may be determined. In the case of a patch-administeredmedication, for example, signals may be sent and/or received (e.g., viathe patient's body) to determine that the medicated patch has beenapplied to the patient's skin.

The compliance module 110 may, for example, comprise a medicalinformation bracelet, tag, and/or device (such as a MedicAlert® braceletor E-HealthKey™) that may detect signals sent through and/or via apatient's body (e.g., indicating application of a medicated patch and/oringestion or application of a medication). In some embodiments, thecompliance module 110 may comprise a necklace, earring, and/or otherdevice capable of detecting proximity of a pill. Each pill to be takenby a patient may, for example, be coupled with a Radio FrequencyIDentification (RFID) device that a compliance necklace may detect uponswallowing by a patient. According to some embodiments, the RFID deviceon the pill may only be activated upon exposure to saliva so that falseswallow indications may be less likely.

According to some embodiments, a patient may be supplied with more thanone compliance device and/or more than one potential compliance deviceso that the patient may be less likely to be able to falsify compliancedata. A patient may be supplied with a compliance-tracking pill bottle(and/or cap) as well as a compliance-tracking bracelet, for example. Insome embodiments, both compliance devices may record and track eventsand the data may be compared to verify accuracy, identify errors, and/ordiscover tampering efforts. According to some embodiments, tracking maybe alternated (e.g., randomly and/or in accordance with a pre-definedpattern) between the devices, so that the patient may not be aware whichdevice is actively tracking compliance data at any given time.

In some embodiments, movement, proximity, and/or other metricsassociated with a substance and/or substance container may bedetermined. A pressure-sensitive pad (such as a “compliance pad” asdescribed herein) may, for example, be utilized to determine if acontainer is picked-up, moved, and/or if a quantity of a substance hasbeen removed from the container (e.g., such as in the case that the padmay be capable of detecting or measuring mass, weight, or other forcesor metrics).

In some embodiments, a sensor and/or circuit may be utilized to detectthe immersion of a syringe into a particular substance. The immersionmay, for example, complete a circuit and/or alter a voltage orresistance/impedance in a particularly pre-defined manner that indicatesimmersion into a substance having certain properties. According to someembodiments, an accelerometer and/or other sensor may detect pill bottlecap removals and/or movements, and/or may detect the shaking of a vial(e.g., which may be required prior to ingestion of a medicationcontained therein).

In some embodiments, compliance with a condition associated with thetaking of the substance may be determined and/or analyzed. Whether anidentified event occurrence is compliant with, satisfies (and/orpartially satisfies), and/or is otherwise associated with a conditionsuch as a prescription, therapy, and/or regimen condition, may, forexample, be determined (e.g., by the compliance module 110 and/or byanother device or entity). In some embodiments, an indication of suchcompliance may be generated and/or stored. The indication may, forexample, be indicative of whether or not a condition associated with thetaking of the substance is satisfied and/or complied with. Cap removaldata may, for example, represent an indication of whether or not acontainer cap is removed within the parameters described by aprescription. A stored indication of such an event may, according tosome embodiments, comprise a positive value in the case that the patientremoves the cap once every day between the hours of 3:00 PM and 9:00 PM,and may comprise a negative value in the case that one or more dayselapse in which the cap is not removed within the appropriate timewindow. Any other values (such as values indicating partial compliance)that are or become practicable may also or alternatively be generatedand/or stored.

In some embodiments, an indication of the compliance status may beprovided to the patient and/or to another entity. The patient may, forexample, press a button on the compliance module 110 to indicate arequest for the current compliance status. The status may then beindicated to the patient, for example, via one or more displays, sounds,and/or visual indicators (e.g., lights). According to some embodiments,one or more Light-Emitting Diode (LED) devices may be utilized toindicate the current compliance status. A green LED may indicatecompliance, for example, while a red LED may indicate non-compliance. Insome embodiments, such as in the case that compliance is determined inaccordance with a continuum, a yellow or orange LED may indicate partialcompliance and/or near non-compliance. In some embodiments, a value of acompliance metric may be provided (e.g., via voice, sounds, and/or via adisplay device). The text “90%” may, for example, be displayed to thepatient to indicate that the patient is currently ninety percentcompliant (e.g., with respect to when, how often, how much, and/or whichmedications or other substances have been taken).

In some embodiments, the compliance module 110 may actively provide anindication of compliance to the patient. In the case that the compliancemodule 110 comprises a device capable of receiving signals from a heartrate monitor, for example, the compliance module 110 may provideindications to the patient associated with the patient's current heartrate (e.g., during exercise). According to some embodiments, thecompliance module 110 may also or alternatively act to affect thepatient's heart rate and/or other compliance-related metric, such as byaltering the difficulty, slope, and/or speed of a treadmill to activelytailor the patient's workout to comply with one or more health careand/or exercise regimens (with or without the patient's knowledge orawareness). In some embodiments, the provided indication may alsorepresent other data. A patient may press a button to receive anindication as to the status of a game, for example.

The method 200 may continue, according to some embodiments, bydetermining output information associated with a game, at 204. Theoutput may be determined, for example, to facilitate improved compliancewith a patient's prescription regimen. According to some embodiments,the output may be determined based on a prescription regimen. In thecase that a patient is supposed to take a pill every day between 4:00 PMand 6:00 PM (e.g., with dinner), for example, the game output may bedetermined to coincide with the prescription window (e.g., may bedetermined, near, and/or before 4:00 PM). In some embodiments, theoutput may be determined based on the occurrence of the event (and/orthe identification of the occurrence). Every time a patient opens acontainer associated with a substance, for example, the output may begenerated and/or otherwise determined. According to some embodiments,the output may be determined only in the case that the occurrence of theevent is in compliance with the prescription. It may not be desirable,for example, to determine game output unless a patient's actions are inconformance with a health care regimen.

In some embodiments, the output may comprise a code that may bedetermined to be indicative of the occurrence of the event. The codeindicative of the event may, for example, be coded and/or encrypted toresemble a form of game output such as a bingo number, a lottery number,and/or any other type or form of code, coordinate, and/or game-relateddata. In some embodiments, such a code may be utilized both to indicatecompliance (or non-compliance) with a prescription and to determine oneor more actions or outcomes related to a game. According to someembodiments, codes generated to be indicative of non-compliant eventsmay be utilized and/or effective as “losing” and/or otherwise negativeresult-oriented game output, for example, while codes indicative ofcompliant events may be utilized and/or effective as “winning” and/orpositive result-oriented games output. In such a manner, for example,patients that are compliant may be more likely to win a game (e.g.,associated with the compliance module 110), while non-compliant (and/orless compliant) patients may be less likely to achieve positive gameresults. In some embodiments, the compliance module 110 may be providedwith information associated with a game (such as the layout of a bingo,minesweeper, and/or battleship board) to facilitate generation of“winning” and/or “losing” game outputs.

According to some embodiments, the amount, quantity, and/or type of gameoutput may also or alternatively be based on the occurrence of the eventand/or an associated prescription. In some embodiments, the probabilityof achieving a winning result via the game output may be based on apatient's compliance. More compliant patients may be entered into afirst, smaller drawing or sweepstakes, for example, providing each suchcompliant patient with relatively high chances of winning. While lesscompliant patients may be entered into a second, larger drawing orsweepstakes, providing each such patient with larger (or worse) odds ofachieving a winning result. Payout tables and/or other metrics utilizedto determine the game output may also or alternatively be managed,manipulated, and/or altered based on a patient's compliance.

In some embodiments, the quantity of game output may be managed. In thecase that the game output comprises one or more bingo numbers, forexample, more bingo numbers may be provided to patients achieving highercompliance, while non-compliant and/or minimally compliant patients maynot receive any bingo numbers. In some embodiments, the quantity of gameoutput may be varied in accordance with one or more prescriptionfrequencies. In the case that only one bingo number is provided everytime a patient takes a pill, for example, even among patients of equalcompliance, those patients with higher frequency prescription doses mayhave an advantage (e.g., receiving more game output may increase chancesof winning). Patients required to take a pill every day may receivethirty (30) bingo numbers a month, for example, while patients onlyrequired to take a pill once a week may only receive four (4) bingonumbers a month. In order to manipulate, equalize, standardize, and/orotherwise determine the quantity of game output, according to someembodiments, a desirable amount of output per time period may bedetermined. In the case that it may be desirable for all patients ofequivalent compliance (e.g., in the same compliance group) to receivethirty (30) bingo numbers per month, for example, the amount of gameoutput to be determined may be calculated by the following formula:G=T/nwhere “G” is the quantity of game output (e.g., such as bingo or othernumbers or codes), “T” is the total desired quantity of game output fora given time period, and “n” is the number of times a prescription,therapy, and/or other health care regimen event is to occur during thetime period.

The method 200 may continue, according to some embodiments, by providingthe output information to the patient, at 206. The game outputdetermined at 204, for example, may be displayed, transmitted, and/orotherwise provided to the patient. According to some embodiments, asubset of the game output determined at 204 may be provided to thepatient. In the case that the game information is determined every timean event (such as the opening of a pill bottle) is detected, forexample, the game output may only be provided to the patient if theevent is determined to be in compliance with a prescription. This mayprevent, for example, a patient from obtaining more game output bysimply opening and closing a pill bottle repeatedly, when not requiredto do so by a prescription. In some embodiments, particular game outputthat is determined at 204 may be selected for providing to the patient.Multiple game output may be determined for various circumstances such ascompliance, partial compliance, or non-compliance, for example, andbased on a determination of a patient's compliance, the correspondingand/or appropriate game output may be selected to be provided to thepatient.

According to some embodiments, the output information may be directlydisplayed to the patient. The compliance module 110 may, for example,comprise a display device capable of providing images and/or other datato the patient. Any code or other game or compliance-related informationmay be displayed via such a device for viewing by the patient. Theoutput may also or alternatively be transmitted to one or more otherdevices. One or more devices associated with the patient (such as theuser device 140) may, for example, receive the output. Such devices mayinclude, but are not limited to, a computer, a PDA, a watch, a TV, atelephone, a pager, and/or any combination of these and/or other deviceassociated with the patient. The patient may then utilize the device toprovide the information to a system (such as the controller 150) and/orentity that may provide rewards to the patient based at least in part onthe patient's compliance and/or upon the game output. According to someembodiments, the output may be otherwise provided to the patient. Theoutput may be spoken, sounded, and/or provided via blinking lightsand/or other indicators, for example. In some embodiments, the outputmay comprise sound and/or tone output that a patient may simply provideto a telephone (e.g., by holding a compliance module near the receiver)such that the information may be automatically transmitted to anotherdevice such as a controller.

In some embodiments, the game output provided to the patient maycomprise information not directly associated with a typical “game”. Thegame output may comprise, for example, animated representations of anartificial creature and/or an artificial intelligence (e.g., aTamagotchi™). The occurrence of a patient's prescription-compliantevents may be necessary, for example, for a patient to maintain the“health” and/or “life” of a displayed and/or rendered cyber-pet.Patients that are compliant and/or substantially compliant, for example,may be presented with game output indicating that their “pet” has grown,learned more skills or words, and/or is otherwise doing well.Non-compliant patients, however, may be presented with game outputindicating that the “pet” is hungry, sick, or even dying. According tosome embodiments, a “pet” may be shown to suffer maladies and/orsymptoms consistent with common problems the patient may suffer ifmedications or treatment regimes are not followed properly (e.g., asforeshadowing of what may occur if the patient does not improvecompliance).

According to some embodiments, the game output provided to the patientmay comprise various sounds, pictures, and/or other media (e.g., video)intended to motivate the patient to comply with a prescription. Suchmedia may comprise, according to some embodiments, pictures of friends,family members, or celebrities (and/or other desirable and/ormotivational pictures) or sounds and/or voice recordings of friends,family members, or celebrities (and/or other motivational sounds orvoice like “Good Job!”). A patient's complaint actions may, for example,cause pictures of grandchildren to be displayed and/or pre-recordedvoice tracks from a spouse or other loved-one to be played (e.g., aspositive motivation). According to some embodiments, non-compliantevents may trigger a direct cellular telephone and/or othercommunication with a family member and/or health care provider so thatthe patient may be provided with live support to facilitate and/orencourage compliance.

In some embodiments, the pictures and/or portions thereof may fadeand/or disappear in response to non-compliance by a patient. In someembodiments, a picture and/or representation or indication of anavailable prize (such as a picture of a tropical island representing anavailable prize trip to Hawaii), for example, may be displayed.According to some embodiments, the displayed prize picture may fade inrelation to decreased and/or diminished compliance of a patient (e.g.,indicating that the patient's chance of winning the prize is “slippingaway”).

According to some embodiments, the game output may be provided tostimulate other senses. The game output may comprise, for example, anolfactory indicator such as a pleasing scent. In some embodiments, theolfactory indicator may comprise one or more scents associated with anaromatherapy treatment or may otherwise be configured to facilitatecompliance by pleasing or alerting a patient's sense of smell. The scentmay, for example, be configured to remind the patient of a pleasingexperience and/or to otherwise indicate that the time has come to take apill or perform a treatment action.

Compliance Module

Turning to FIG. 3, a block diagram of a compliance module 310 accordingto some embodiments is shown. In some embodiments, the compliance module310 may be similar in configuration and/or functionality to thecompliance module 110 described in conjunction with FIG. 1. Thecompliance module 310 may, for example, be utilized to monitor and/orrecord prescription-related events and/or to provide game output topatients to facilitate improved prescription compliance. The compliancemodule 310 may also or alternatively execute, process, and/or otherwisebe associated with the method 200 described in conjunction with FIG. 2.In some embodiments, the compliance module 310 may comprise a processor312, a sensor 314, a clock 316, an input device 318, an output device320, and/or a data storage device 322. According to some embodiments,the data storage device 322 may store encoding process instructions 324,game instructions 326, event data 330, condition data 332, and/or gamedata 334. In some embodiments, fewer or more components, instructions,and/or data than are shown in FIG. 3 may be included in the compliancemodule 310.

According to some embodiments, the processor 312 may be or include anytype, quantity, and/or configuration of processor that is or becomesknown. The processor 312 may comprise, for example, an Intel® IXP 2800network processor or an Intel® XEON™ Processor coupled with an Intel®E7501 chipset. In some embodiments, the processor 312 may comprisemultiple inter-connected processors, microprocessors, and/ormicro-engines. According to some embodiments, the processor 312 (and/orthe compliance module 310 and/or other components thereof) may besupplied power via a power supply (not shown) such as a battery, anAlternating Current (AC) source, a Direct Current (DC) source, an AC/DCadapter, solar cells, and/or an inertial generator. A Lithium-ion(Li-ion), Nickel Cadmium (NiCad), and/or Nickel Metal Hydride (NiMH)battery may, for example, supply the necessary voltage and/or amperageto power any or all of the components of the compliance module 310.According to some embodiments, the processor 312 may receive signalsfrom the sensor 314. The sensor 314 may, for example, comprise one ormore sensors configured and/or coupled to identify, detect, and/orotherwise determine the occurrence of an event associated with thetaking of a substance by a patient.

The sensor 314 may, according to some embodiments, comprise a switchthat is coupled to engage in the case that a cap and/or top to acontainer is opened and/or to disengage in the case that the cap and/ortop is closed, latched, and/or otherwise secured. In some embodiments,the sensor 314 may supply the processor 312 with an indication of thenumber of times that the cap and/or top has been removed and/orreplaced. Any type, quantity, and/or configuration of sensor 314 that isoperable to identify, detect, and/or otherwise determine the occurrenceof a prescription-related event may be utilized. Electrical, electronic,magnetic, and/or mercury switches, pressure sensors, stress sensors,motion sensors, weight sensors, light sensors (including lasers),thermal sensors, acoustic sensors, triggers, gates, switches, barcode orother electronic readers and/or scanners, signal receivers, and/or anyother type of sensing device that is or becomes practicable may, forexample, comprise the sensor 314.

Examples of sensors 314 may include, but are not limited to, thosedescribed in U.S. Pat. No. 4,939,705 to Hamilton, et al. and U.S. Pat.No. 4,616,316 to Hanpeter et al., which are incorporated by referenceherein. The type of sensor described by Hanpeter, for example, consistsof a blister pack with an array of plastic blisters that definecompartments for medication. The backing sheet comprises conductivetraces that are respectively ruptured when the medication doses areremoved. An electronic memory circuit detects the ruptures and storesthe data over a period of time. In some embodiments, other types ofsensors 314 may also or alternatively be used. The sensor 314 may, forexample, comprise a passive-inductive device, a RF receiver, and/or anRFID reader and/or device. The sensor 314 may, for example, be operableto receive signals from, identify, and/or detect a prescription-relateddevice (such as a medicine bottle or container) and/or may be operableto measure metrics associated therewith (e.g., location identification,position information, mass, weight, movement, light transmittance,and/or other information).

According to some embodiments, signals and/or data generated by thesensor 314 may be provided to the processor 312. Such signals and/ordata may be indicative of a variety of metrics and/or other informationassociated with the taking of the substance by a patient. The data maycomprise, for example, the number of cap, top, and/or lid removals in aparticular time period, a date and time of each of the last twenty (20)removals, durations of removal events, a number of pills dispensed overa given period of time, an amount of a substance removed from acontainer, movements of a container, etc. Such data may be provided tothe processor 312 on a continuous, intermittent, and/or as-need basis.The sensor 314 and the processor 312 need not, for example, be inconstant communication.

According to some embodiments, the sensor 314 may transmit the data tothe processor 312 a fixed number of times within a given time period.For example, a maximum number of transmitted cap removals and/or otherevents within a twenty-four (24) hour period might be two. Such arestriction would make it impossible for a patient to generate false capremoval data (e.g., in the case of a pill bottle) by repeatedly openingand closing the cap within a short period of time. A patient with amonth long prescription, for example, might realize at the end of themonth that he had forgotten to take his medication. Trying to generate amonth's worth or cap removal data would be futile since only two capremoval events would be recorded within each twenty four hour period.

In some embodiments, the compliance module 310 may include the clock316. The clock 316 may, for example, facilitate the compilation,generation, and/or storage of time-related data. According to someembodiments, the clock 316 may maintain an internal (e.g., with respectto the compliance module 310) representation of the time/date and may beused to provide a timestamp that may augment the data provided by thesensor 314. The clock 316 may, for example, be used to track time ofday, date, day of week or any other type or configuration ofchronographic measurement that is or becomes known. In some embodiments,the clock 316 may provide one or more clock signals to the processor 312and/or the sensor 314 to synchronize, coordinate, manage, and/orfacilitate data transmissions and/or analysis.

According to some embodiments, the clock 316 may be incorporated as partof the processor 312. The clock 316 may, for example, comprise anon-chip or on-die clock circuit incorporated as part of a CentralProcessing Unit (CPU) that also includes the processor 312. In someembodiments, the clock 316 may comprise an external source that providestime-related data to the compliance module 310 and/or componentsthereof. The clock 316 may, for example, comprise a device associatedwith receiving and/or providing standardized time information such asthat obtainable from an atomic and/or atomic fountain clock like theNational Institute of Standards and Technology-F1 (NIST-F1) cesiumfountain atomic clock located in Boulder, Colo., that definesCoordinated Universal Time (“UTC”).

In some embodiments, the compliance module 310 may comprise the inputdevice 318. The input device 318 may be or include any type, quantity,and/or configuration of input device that is or becomes known orpracticable. The input device 318 may comprise, for example, a keyboard,a keypad, a pointing device (such as a mouse or trackball), one or morebuttons or switches, a biometric device, such as a fingerprint orretinal scanner, a magnetic card reader or smart card reader, and/or oneor more softkeys and/or variable function input devices. According tosome embodiments, the input device 318 may be utilized by a patient toprovide information to the compliance module 310. The patient mayprovide (and/or the compliance module 310 may otherwise receive), forexample, input such as a user identifier, a cap, container, and/or“compliance pad” identifier, an insurance policy identifier, and/or aprescription identifier. In some embodiments, the input device 318 maycomprise voice recognition capability to allow a patient (and/or otheruser or entity) to provide verbal information to the compliance module310. The patient may, for example, speak a code word and/or provideother voice input to the input device 318. The input device 318 may thenprovide an indication of such input to the processor 312 (e.g., forpatient identification and/or other purposes).

In some embodiments, the compliance module 310 may also or alternativelycomprise the output device 320. The output device 320 may, for example,be or include any type of output device that is or becomes known orpracticable. Examples of output devices 320 may include, but are notlimited to, a printer, a speaker, a modem, a Network Interface Card(NIC), a port, a path, a cable, a Cathode Ray Tube (CRT) display device,a Liquid Crystal Display (LCD) device, and/or an LED display device.According to some embodiments, information associated with any of theprocessor 312, the sensor 314, the clock 316, and/or the input device318 may be provided, transmitted, and/or displayed via the output device320. The output device 320 may, for example, comprise a display screento provide various information to a patient and/or other entity. In someembodiments, the output device 320 may be utilized to provideinformation processed by the processor 312 and/or information stored viathe data storage device 322.

The data storage device 322 may, for example, store the encoding processinstructions 324 and/or the game instructions 326 that may be utilizedby the processor 312 to provide output information via the output device318. The data storage device 322 may comprise any appropriateinformation storage device that is or becomes known or available,including, but not limited to, units and/or combinations of magneticstorage devices (e.g., a hard disk drive), optical storage devices,and/or semiconductor memory devices such as Random Access Memory (RAM)devices, Read Only Memory (ROM) devices, Single Data Rate Random AccessMemory (SDR-RAM), Double Data Rate Random Access Memory (DDR-RAM),and/or Programmable Read Only Memory (PROM).

According to some embodiments, the encoding instructions 324 may beoperable to cause the processor 312 to encode information. Informationreceived from any of the sensor 314, the clock 316, and/or the inputdevice 318 may, for example, be encoded by the processor 312 inaccordance with the encoding instructions 324. Encoding data may providemany advantages. Without knowing how the data is encoded, for example, apatient and/or other entity (e.g., other than a decoding entity) may notbe able to (or may not be easily able to) falsify the data. In the casethat the data is indicative of prescription-related events and/or gameinformation, for example, encoding may facilitate accurate and securestorage and/or transmission of compliance and/or reward-relatedinformation.

The encoding process instructions 324 may comprise, according to someembodiments, one or more encoding and/or encryption protocols to beutilized in encoding data. Examples of various encoding and/orencryption protocols that may be utilized include symmetric keyencryption, public key encryption, hash algorithms, digital signatures,and the like. If lower levels of security are required, substitutionciphers or transposition ciphers may be appropriate. Common types ofencoding are described in “Applied Cryptography, 2nd Edition” by BruceSchneier (1996), the encoding and/or encryption descriptions of whichare incorporated herein.

In some embodiments, the data encoded by the processor 312 (e.g.,utilizing the encoding process instructions 324) may compriseprescription compliance information. The number of cap, top, and/or lidremovals in a given time period may, for example, be encoded by theprocessor 312. According to some embodiments, other data may also oralternatively be encoded. Examples of other data may include useridentifiers, cap and/or container identifiers, insurance identifiers,account identifiers, compliance module 110, 310 identifiers, a beginningtimestamp and an ending timestamp.

The patient may, for example, enter the number of pills that are takenat each cap removal event, entering the information via the input device318. In some embodiments, a cap identifier (and/or other information)may be concatenated and/or otherwise combined with the cap removal data.The resulting combined data may then, for example, be encoded by theprocessor 312. One advantage of such an embodiment is that when theencoded cap removal data is decoded, the identity of the cap (and/orpatient, compliance module 310, etc.) may be authenticated in additionto the number of cap removals, preventing a user from providing theencoded cap removal data from another patient's compliance module 310.The encoding process instructions 324 may also provide instructionsassociated with an integrity test. An indication of a security breach(e.g., tampering) associated with the compliance module 310 (e.g.,detected by the sensor 314) may be concatenated and/or otherwiseincluded with the cap removal data prior to the encoding process, forexample. Decoding may subsequently reveal evidence of the breach (e.g.,and be used to invalidate the compliance results).

In some embodiments, the game instructions 326 may be operable to causethe processor 312 to execute and/or otherwise process data in accordancewith one or more games. Upon the detection of an event (e.g., via thesensor 314), for example, the processor may execute the gameinstructions 326 to provide game-related data to the patient (e.g., viathe output device 320). According to some embodiments, the gameinstructions 326 may include complete code capable of executing,performing, and/or rendering an entire game. In some embodiments, thegame instructions 326 may simply comprise instructions associated withgame output (e.g., moves, actions, and/or coordinates) and/or gameresults (e.g., win, loss, and/or other particular outcomes). Accordingto some embodiments, the game instructions 326 may comprise instructionsfor determining game-related output, actions, hints, codes, and/orresults based upon prescription and/or prescription compliance events.The game instructions 326 may also or alternatively compriseinstructions relating to the control or operation of a separate device.

In some embodiments for example, the game instructions 326 may cause thecompliance module 310 and/or the output device 320 thereof tocommunicate with and/or control another device such as a TV. In the casethat a patient is determined to be non-compliant (such as by missing amedication dose), for example, the game instructions 326 may cause thecompliance module 310 to send a signal to the TV to turn the TV off,disable video inputs to the TV (such as video game console inputs), orto cause a “V-chip” in the TV to block certain types or instances ofprogramming. In such a manner, for example, patients (particularlychildren) may be motivated to be compliant with a prescription in orderto preserve or obtain TV, movie, and/or video game usage. In someembodiments, compliance events such as taking a pill or medication maybe scheduled to be coincident with a particular program, such as afavorite TV program, to further facilitate compliance (e.g., either bysimply enhancing remembrance or by blocking the program unless thecompliance event occurs).

The data storage device 322 may also or alternatively store the eventdata 330, the condition data 332, and/or the game data 334. Any or allof these and other types of data may be stored in any number, type,and/or configuration of data storage structures (such as the datastorage structures described elsewhere herein) that is or becomes known.The data storage device 322 may, for example, comprise one or more datatables or files, databases, table spaces, registers, and/or otherstorage structures. In some embodiments, multiple databases and/orstorage structures (and/or multiple data storage devices 322) may beutilized to store information associated with the compliance module 310.According to some embodiments, the data storage device 322 may beincorporated into and/or otherwise coupled to the compliance module 310(e.g., as shown) or may simply be accessible to the compliance module310 (e.g., externally located and/or situated).

The event data 330 may comprise data associated with events detected,identified, and/or determined by the sensor 314. Events associated withthe taking of a substance by a patient, for example, may be detected bythe sensor 314 and recorded (e.g., as effectuated by the processor 312)as the event data 330. The event data 330 associated with multipleevents (e.g., a months worth of pill bottle openings) may be stored, forexample, and then encoded by the processor 312 by executing the encodingprocess instructions 324. In some embodiments, the condition data 332may also or alternatively be stored in the data storage device 322. Thecondition data 332 may comprise, for example, data associated withprescriptions, therapies, and/or other health care regimens. Accordingto some embodiments, the condition data 332 may define one or moreconditions and/or time periods associated with such prescriptions. Thecondition data 332 may be utilized by the processor 312, for example, todetermine if detected events are compliant with the prescriptionconditions. The game instructions 326 may only be executed (and/or mayonly produce positive results), for example, in the case that an eventoccurs that is complaint with the condition data 332.

In some embodiments, either or both of the instructions 324, 326 and thedata 330, 332, 334 stored in the data storage device 322 may be capableof being updated periodically as is desirable. As new prescriptions,games, and/or other information become available, for example, the datastorage device 322 may be updated (e.g., via the input device 318).According to some embodiments, the patient may utilize the compliancemodule 310 in conjunction with various prescriptions and/orprescription-related devices (e.g., pill bottles). Each time the patientgoes back to the pharmacy he may be provided, for example, with a newpill container and new pills. The patient may bring the compliancemodule 310, in some embodiments, so that data 330, 332, 334 and/orinstructions 324, 326 stored in the data storage device 322 may beupdated. In this way, revised prescription data may be convenientlyentered. The compliance module 310 may also or alternatively be incommunication with a server such as the controller 150, so that anyupdates may be easily and/or automatically executed (e.g., wirelesslyand/or remotely).

The game data 334 may comprise any game-related data that is or becomesknown or practicable. The game data 334 may, for example, include dataindicative of one or more game boards (e.g., bingo boards, battleshipboards, minesweeper and/or minesweeper-style boards), card decks (and/orshoes), maps, scratch tickets, and/or other game objects. The game data334 may also or alternatively include one or more moves, actions,values, results, outcomes, pay tables, probability tables, and/or othermetrics associated with one or more games. In some embodiments, the gamedata 334 may comprise one or more files such as picture, sounds, movie,and/or other audio or video files. According to some embodiments, thegame data 334 may be utilized by the processor 312 in executing the gameinstructions 326. The processor 312 may load one or more lottery and/orbingo numbers from the game data 334, for example, to be provided to acomplaint patient via the output device 320. These and other aspects ofthe various types of stored data according to some embodiments aredescribed in more detail with reference to FIG. 4A, FIG. 4B, and FIG.4C.

Compliance Module Data Tables

Referring now to FIG. 4A, FIG. 4B, and FIG. 4C, block diagrams of datatables 430, 432, 434 according to some embodiments are shown,respectively. In some embodiments, the data tables 430, 432, 434 may besimilar in configuration and/or content to the data 330, 332, 334 and/ordata tables described in conjunction with FIG. 3. Any or all of the datatables 430, 432, 434 may, for example, be stored in and/or otherwiseassociated with the compliance module 110, 310. According to someembodiments, an event data table 430 may store event-relatedinformation, a condition data table 432 may store information associatedwith health care conditions, and/or a game data table 434 may storegame-related information, for example. In some embodiments, fewer ormore data fields than are shown may be associated with the data tables430, 432, 434. Only a portion of one or more databases and/or other datastores is necessarily shown in any of FIG. 4A, FIG. 4B, and/or FIG. 4C,for example, and other database fields, columns, structures,orientations, quantities, and/or configurations may be utilized withoutdeviating from the scope of some embodiments. Similarly, the data shownin the various data fields is provided solely for exemplary andillustrative purposes and does not limit the scope of embodimentsdescribed herein.

According to some embodiments, such as shown in FIG. 4A for example, theevent data table 430 may comprise various data fields such as an“event_id” field 430-1, an “event_type” field 430-2, and/or an“event_time field” 430-3. The “event_id” field 430-1 may, for example,simply store an identifier for each event and/or event occurrence thatis recorded in the event data table 430. Each occurrence of an eventdetected by the sensor 314 may, for example, be represented by a uniqueidentifier such as an alphanumeric code stored in the “event_id” field430-1. Stored events may also or alternatively be identified and/ordescribed by event types stored in the “event_type” field 430-2. Asshown in FIG. 4A, for example, various event types such as “cap_open”,“cap_closed”, and “patch_applied” may correspond to health caresubstance (e.g., medication and/or supplement) container openings andclosing as well as medicated patch applications, respectively. Manyother types of events may also or alternatively be stored and/oridentified. Other examples of event types may include, for example,container movements, changes in container weight (e.g., “pill_removed”),emptying or re-filling of a container, and/or use of various medical orhealth care-related devices (e.g., “inhaler_dosed” or “brace_engaged”).

In some embodiments, the time and/or date of every event may be recordedin the “event_time” field 430-3. The clock 316 may be utilized, forexample, to determine a specific time (and/or time range or window) inwhich any given event occurs. Many ancillary time-related metrics maythen, according to some embodiments, be calculated based on the storedtime stamps. With reference to the exemplary data of the event datatable 430, for example, it is recorded (in the first data record) thatthe cap to a container was opened on the fifth of August at nineeighteen and forty-three seconds in the morning (“Aug. 9, 200509:18.43”) and then (in the second data record) closed on the fifth ofAugust at nine eighteen and fifty-two seconds in the morning (“Aug. 9,2005 09:18.52”). Any processing device (such as the processor 312) maysimply calculate that the amount of time that the cap remained open wasnine (9) seconds. Such information may be advantageous to determine, forexample, if the cap was accidentally opened (e.g., the elapsed time maybe determined to be too short for a patient to have removed a pill)and/or if the cap was accidentally left open (e.g., a long period oftime elapses before the cap is closed). It may also be advantageoussimply to know when a substance and/or regimen was applied. Certainmedicines are more effective at certain times of the day, for example,and certain medications and/or therapies may not be effective ifrepeated too soon or if too much time elapses between doses.

According to some embodiments, such as shown in FIG. 4B for example, thecondition data table 432 may comprise various data fields such as a“condition_id” field 432-1, a “condition_type” field 432-2, and/or a“condition_description” field 432-3. The condition data table 432 maystore information associated with various conditions relating toprescriptions, therapies, and/or other health care regimens. The“condition_id” field 432-1 may simply store an identifier (such as aunique identifier) for each recorded condition, for example, while the“condition_type” field 432-2 may store a classification and/or groupingassociated with the conditions. As shown in FIG. 4A, for example, someconditions may be associated with a “prescription”, others may beassociated with “dietary” regimens, and/or others may be less-stringentand/or simply “recommended” conditions. Many other classifications may,of course, also or alternatively be practicable. In some embodiments,the “condition_description” field 432-3 may contain a description and/ordefinition associated with a respective condition.

With reference to the exemplary data stored in the condition data table432, for example, it is shown that condition “C-0100” (the first datarecord) defines a condition that a patient must take a pill once a day.In some embodiments, a type, description, and/or identification of theparticular pill (or other substance) associated with the condition mayalso be stored. Such information may also or alternatively be accessiblevia a linked table such as a “prescription” and/or “medication” table(not shown). The second condition “C-0101” is shown as indicating a“recommended” condition that the pill be taken during a time windowbetween eight and nine in the morning. In some embodiments, such“recommended” and/or secondary conditions may be utilized to providerewards and/or specific game output to different patients. While anypatient satisfying condition “C-0100” by taking a pill once a day may bedeemed complaint, for example, those patients satisfying the“recommended” condition “C-0101” may be considered “more” complaintand/or may otherwise be more highly rewarded (e.g., given more lotterynumbers, more sweepstakes entries, and/or more bingo numbers or gamehints).

According to some embodiments, such as shown in FIG. 4C for example, thegame data table 434 may comprise various data fields such as a “game_id”field 434-1, a “game_name” field 434-2, “game_data1” field 434-3, and/ora “game_data2” field 434-4. The game data table 434 may storeinformation associated with various games used to facilitate and/orenhance patient compliance with prescriptions and the related conditionsstored in the condition data table 432. The “game_id” field 434-1 maysimply store an identifier (such as a unique identifier) for each game,for example, while the “game_name” field 434-2 may store a name of eachgame. The games shown in FIG. 4C, for example, are “bingo”, “lotto”, and“minesweeper”. Many other games may also or alternatively be storedand/or used as described elsewhere herein.

In some embodiments, the game data fields 434-3, 434-4 may store gameoutput (such as the game output determined at 204 in the method 200)and/or other game-related data. As shown, for example, the exemplaryrecords store multiple bingo numbers, lotto numbers, and coordinates,respectively. According to some embodiments, one of these numbers may beprovided each time a patient performs a prescription-complaint act. Insome embodiments, multiple game output numbers may be provided at anyone given time. Accordingly, many game output values may be stored inmany more game data fields than are shown in FIG. 4C. In someembodiments, a single game data field may be utilized that links to oneor more other fields and/or tables that contain an appropriate amount ofgame output data. According to some embodiments, the game data fieldsmay simply comprise one or more random number seeds to be utilized bythe processor 312 to generate game output (e.g., in accordance with thegame instructions 326).

Compliance Games

Referring now to FIG. 5A and FIG. 5B, a perspective diagram and a planview of a compliance module 510 according to some embodiments, are shownrespectively. In some embodiments, the compliance module 510 may besimilar in configuration and/or functionality to any of the compliancemodules 110, 310 described in conjunction with any of FIG. 1 and/or FIG.3 herein. The compliance module 510 may comprise, for example, one ormore output devices 520 a-b coupled to a container 582 and/or a cap 584thereof. The container 582 may, according to some embodiments, be orinclude any type or configuration of container such as a standard eight,sixteen, thirty, or forty dram (8, 16, 30, or 40-dr) amber clarifiedpolypropylene prescription vial with a child-proof, threaded, or snapcap, manufactured by Pharmacy Lite Packaging, Inc. or Pacific ManagementHoldings (PMH) Manufacturing and Design, LLC, both of Elyria, Ohio. Thecontainer 582 may also, of course, comprise any form, shape, size,and/or configuration of container for storing and/or housing healthcare-related substances or devices that is or becomes known orpracticable.

In some embodiments, such as in the case that the container 582comprises a standard prescription vial (e.g., as shown in FIG. 5A andFIG. 5B), a label 586 may be printed thereon and/or otherwise coupledthereto. The label 586 may, for example, display information such aspatient information, pharmacy information, insurance information, and/orcondition information 588. According to some embodiments, the conditioninformation 588 may be similar to and/or include the condition data 332.In some embodiments, fewer or more components that are shown in FIG. 5Aand/or FIG. 5B may be included in or as part of the compliance module510.

According to some embodiments, the compliance module 510 may comprisealternate and/or various forms. The standard container 582 shown in FIG.5A and FIG. 5B, for example, is exemplary in nature and does not limitthe scope of the embodiments described herein. In some embodiments, thecompliance module 510 may be defined as a particular part or componentof and/or may be otherwise associated with the container 582. Instead ofthe entire container 582 defining the compliance module 510, forexample, the container 582 may comprise an entirely standard containerwith the compliance module 510 incorporated into the cap 584 and/orotherwise coupled thereto and/or associated therewith. It should beunderstood that the procedures described herein such as the compliancefacilitation procedures involving the output of game and/or otherinformation may be performed by and/or associated with any configurationof the compliance module 510 that is or becomes practicable.

According to some embodiments, the compliance module 510 may be utilizedto identify, record, and/or otherwise determine whether a patient iscompliant with various conditions (such as the condition 588) of aprescription. The compliance module 510 may, for example, identifyvarious events (e.g., at 202) associated with the taking of a substanceby the patient. The compliance module 510 may also or alternativelyprovide game output to the patient (e.g., at 206) to facilitate patientcompliance with the prescription.

Applicants have recognized, for example, that many persons enjoy playinggames and look forward to the moment at which the result of a game isrevealed. For example, many persons enjoy playing games of chance suchas slot machine games and greatly enjoy the moment when the reels of theslot machine stop along a payline to reveal the result of the game.Applicants have further recognized that taking medicine (or otherwisecomplying with a prescription) is typically not an entertaining orenjoyable experience, which is one of the reasons many people eitherforget or avoid taking their medicine in compliance with theprescription. Accordingly, Applicants have recognized that providing agame interface and/or revealing results of a game (or other game output)in response to the taking of a substance by a patient will be aparticularly powerful and effective method for motivating patients totake their medicine and/or otherwise comply with their prescriptions,therapies, or health care regimens.

According to some embodiments, such as shown in FIG. 5A and FIG. 5B forexample, the one or more output devices 520 a-b of the compliance module510 may be utilized to output game information such as informationassociated with the result of a game. In some embodiments, the result ofa game may be output via an entertaining game interface, such as theslot machine interface shown in FIG. 5B, provided by the one or moreoutput devices 520 a-b. Having the result output via a game interfacewill further enhance, for example, the patient's enjoyment of obtainingthe result of the game. In some embodiments, the label 586 may also oralternatively function as and/or be part of the one or more outputdevices 520 a-b (e.g., the label may be comprised of material operableto output electronic messages, such as a flexible LCD, e-ink™, and/orsimilar substances or materials). The game interface and/or output maybe provided, for example, via the label 586 and/or via more traditionalLCD or other output devices 520 a-b as shown in FIG. 5A and FIG. 5B.

According to some embodiments, the one or more output devices 520 a-bmay be included in, for example, (i) the cap 584 of the container 582;(ii) a cavity defined by the container 528 (not explicitly shown); (iii)the label 586 of the container 582; (iv) another portion of thecontainer 582; (v) a peripheral device associated with the container 582(not shown); or (vi) any combination thereof. The one or more outputdevices 520 a-b may comprise audio or video output devices (such asspeakers or transmitters), printing devices, and/or one or more displaydevices such as an LCD and/or an LED screen. In the case that the one ormore output devices 520 a-b comprise one or more display devices, forexample, information such as still images (e.g., “winner”) or animatedimages (e.g., spinning slot reels) may be shown.

In some embodiments, such as shown in FIG. 5B, the one or more outputdevices 520 a-b may comprise two display screens 520 a, 520 b. It shouldbe understood, however, that any number, type, or configuration ofscreens or other output devices 520 a-b may be utilized, and that anyoutput may be provided via any available output device 520 and/or anycombination of available output devices 520 a-b. In some embodiments,the first display screen 520 a may provide a representation of a resultof a game such as the slot machine interface shown, while the seconddisplay screen 520 b may provide other output information such as gameoutput, encoded game output, and/or encoded compliance data. The resultof a game provided by the first display device 520 a may, for example,be represented by a plurality of symbols displayed along a payline, eachsymbol being displayed on the representation of a respective reel of asimulated slot machine. It should be understood that other interfacesbased on other games or types of games may also or alternatively beused. Other games such as poker, solitaire, bingo, minesweeper,battleship, scratch tickets (such as scratch lottery tickets), and/orany other card, board, question, trivia, and/or video games that are orbecome practicable may be executed by the compliance module 510 and/orprovided via the first display device 520 a thereof.

In some embodiments, the second display device 520 b may displayadditional and/or other information to the patient. For example, thesecond display device 520 b may display a telephone number for thepatient to call, a description of a benefit to be provided to thepatient that corresponds to the result of the game displayed via thefirst display device 520 a, a warning (e.g., “take your pill within thenext hour in order to remain eligible to win a prize”), and/or acompliance or game-related code that the patient may utilize to obtainrewards (e.g., by providing the code to the controller 150). The patientmay call a number provided by the second display device 520 b, forexample, to provide a code (e.g., also provided by the compliance module510) to obtain and/or qualify for a reward.

The code may be displayed via the second display device 520 b and may,for example, comprise a bingo or lotto number, a game coordinate, and/orother game-related information. Such information may be utilized by thepatient, according to some embodiments, to conduct and/or participate ina game. The game may be executed by the compliance module 510 and/or maybe associated with external objects and/or devices. The patient mayutilize bingo numbers provided by the compliance module 510, forexample, to play a bingo card. In some embodiments, the bingo card maybe provided electronically via the first display device 520 a and/or viaan e-ink™ label 586, it may be printed on a standard label 586, engravedor etched on the container 582 and/or the cap 584, and/or may comprise aseparate piece of paper or cardstock.

According to some embodiments, such cardstock (and/or label or othercard or device) may comprise a latex overlay and/or layer configured tobe at least partially scratched-off by a patient. Alternatively, thescratch-off capability may be provided and/or simulated by atouch-screen device such as a flexible LCD display or the like. The cardstock and/or game board may comprise, for example, a small, thin, and/ordisposable touch-screen device coupled to a processor and a battery (orother power source such as a small photovoltaic device), wherein thedevice is capable of simulating a scratch-style ticket or card.

In some embodiments, the latex layer, overlay, and/or simulated scratcharea may be divided and/or segmented into multiple portions such as maybe representative of the various portions of a bingo, minesweeper,minesweeper-type, and/or other game. In some embodiments, the portionsmay be separated by a margin to reduce the possibility that a patientmay accidentally scratch-off an unintended portion. Each such portionmay, according to some embodiments, be associated with one or morecoordinates, codes, and/or game results. Patients may receive, forexample, game output (e.g., for performing compliance-related events)indicative of one or more portions of a game board defined by segmentedportions. The patients may then utilize the game output to identifyparticular portions of the game board to scratch-off. In someembodiments, the latex may be scratched-off to reveal a game result suchas a prize or value. According to some embodiments, patients maycontinue to scratch-off segmented portions until a negative result isrevealed (e.g., a mine). In such a manner, for example, patients maydecide to continue to seek, upgrade, and/or accumulate winnings and riskvoiding the game board (e.g., by revealing a mine and/or other negativeresult), or may choose to redeem the game board for anycurrently-revealed prizes.

In some embodiments, the patient may be provided with a chance to win aprize each time the cap 584 is opened or closed in accordance with acondition of a prescription (e.g., condition 588). The compliance module510 may, for example, comprise a random number generator, a processor(such as the processor 312), a sensor for detecting when the cap 584 isremoved and/or replaced (such as the sensor 314), and/or a memory (suchas the data storage device 322)—none of which are explicitly shown inFIG. 5A or FIG. 5B. The memory may store, for example, a probabilitytable of available results (e.g., symbol combinations to be displayedvia the first display device 520 a and/or coordinates to be provided viathe second display device 520 b), each result corresponding to at leastone random number that may be generated by the random number generator.In some embodiments, the memory may also or alternatively store a payouttable of available prizes, each prize corresponding to one or moreresults that may be displayed via the first or second display devices520 a-b.

Thus, for example, every time the sensor determines that the cap 584 isremoved (or, alternately, that the cap 584 is replaced), the randomnumber generator may generate a random number. The processor may then,for example, access the probability table to determine the result thatcorresponds to the random number and cause one of the display devices520 a-b to display the result. In the case that the memory also stores apayout table, the processor may further access this payout table todetermine the prize corresponding to the result and cause either displaydevice 520 a-b to display an indication (e.g., a graphicalrepresentation or textual description) of the prize. It should be notedthat in some embodiments the patient may separately be provided with alist of the prizes available, and the respective result that each prizecorresponds to. For example, a patient may be provided with a printedlist of prizes and the one or more results corresponding to each prizeand/or may be provided with access to a Web site on which thisinformation is posted. In some embodiments, the prizes available to thepatient may be customized to the patient and/or may be prizes generallyavailable to all patients participating in a system to facilitateincreased prescription compliance.

According to some embodiments, random game results may be generated(either by the compliance module 510 or another computing device) priorto detection of a removal or replacement of the cap 584 (and/ordetection of another event) and stored in the memory. In suchembodiments, rather than generating a random number in response to adetermination that a patient is eligible for a game result, for example,the processor may simply retrieve a game result from memory and outputit to the patient. In some embodiments, the processor may retrieve thenext available game result that has not previously been output to thepatient (such as the game data stored as game data 334 and/or in thegame data table 434).

According to some embodiments, the probability of winning a particularprize and/or the prizes available may be dynamic and/or may otherwisechange. For example, the longer a patient is compliant with prescriptionconditions (and/or the more compliant the patient is), the higher theprobability of winning a prize may become. In another example, morevaluable prizes may be made available to patients of higher and/orlonger compliance. For example, the compliance module 510 may storeinformation (e.g., in the memory) identifying the patient and additionalinformation associated with the identify of the patient that may be usedto determine the probability to be used in determining a game result forthe patient. Such information may include, for example, an indication ofthe patient's current and/or past compliance with prescriptionconditions and/or requirements currently and/or previously associatedwith the patient. In another example, such information may include anindication of the duration for which a condition has been associatedwith the patient (e.g., if the patient has just begun a prescription,the patient may be provided winning game results more frequently toencourage the patient to become used to taking the medication asprescribed).

In some embodiments, the compliance module 510 may be operable tocommunicate with another computing device (e.g., the patient's PC). Forexample, the patient may download software that includes a gameinterface and that is operable to display game results based oninformation received from the compliance module 510. For example, thecompliance module 510 may transmit a code or other instruction to the PCthat causes the software on the PC to provide a game result (e.g., viaan output device associated with the PC). The compliance module 510 maytransmit such code and/or other instruction via, for example, RF and/orInfrared Radiation (IR) signals, a cable connection between thecompliance module 510 and the PC, and/or via the patient, who may beinstructed to manually input the information into the PC. In someembodiments, the compliance module 510 may not include a random numbergenerator and/or table of game results in memory or be operable itselfto display game results. Instead, the PC and/or other device associatedwith the patient (e.g., the user device 140) may comprise these elementsand be operable to perform these functions in response to input from thecompliance module 510. According to some embodiments, both thecompliance module 510 and the computing device may be operable toperform these functions and the patient or another entity may select themethod via which the game results are to be provided (i.e., via thecompliance module 510 and/or via the computing device).

In some embodiments, the patient may be allowed to select one or moregame interfaces and/or games via which results are to be displayed. Forexample, the compliance module 510 may store more than one game and/orgame interface in memory. According to some embodiments, different gamesfrom a plurality of stored and/or available games may be provided to thepatient every time a game result is to be output. Various availablegames may, for example, be executed in a random order and/or in around-robin fashion to maintain the interest of the patient. In someembodiments, the compliance module 510 may be operable to determine oneor more of the available games that the patient may desire, and theseone or more games may be provided to the patient solely or more oftenthan other available games.

In another example, the user may be instructed to visit a Web site thathas downloads of various games and/or game interfaces available and mayselect one of these for download to the memory of the compliance module510. In yet another example, the patient may be asked (e.g., by apharmacist) to select a game and/or game interface when the patienttakes possession of the compliance module 510 and/or obtains a refilland/or otherwise updates the compliance module 510. This selectioninformation and/or other update information may, for example, bedownloaded to the compliance module 510. In yet another example,different compliance modules 510 (such as different container caps 584)may be programmed with different games and/or game interfaces and thepatient may be provided with the appropriate device based on thepatient's selection of a game and/or game interface. An appropriatedevice associated with a particular game may also or alternatively besupplied to patients based on demographic and/or other information(e.g., to increase the likelihood that any given patient may find theprovided game desirable).

In some embodiments, to further motivate a patient to take theirmedicine and/or otherwise comply with a prescription, the compliancemodule 510 may be programmed to initiate a game and/or begin the displayof a game result (e.g., via the output devices 520 a-b) at and/or nearthe times at which the patient is supposed to take their medicine. Thus,for example, one of the representations of a slot machine reel maydisplay symbols along a payline at a time when the patient is supposedto take the medicine. Additionally (or in lieu of beginning a game orthe display of a result of a game), the compliance module 510 may beequipped with an audio output device and may output an audio signal toremind the patient that it is time to take the medicine and/or that thegame or display of a game result has been initiated. In someembodiments, the entire game result may be displayed at the time thepatient is supposed to take the medicine, yet the patient may only beallowed to claim any prize that is associated with the result if thepatient in fact opens and/or re-closes the cap 584 before the full gameresult is displayed. This may further motivate a patient to take theirmedicine in compliance with their prescription, since the patient may bereluctant to chance a winning result being displayed and not being ableto claim the corresponding prize.

In some embodiments, a result of a game may be displayed for apredetermined length of time (e.g., one hour) at and/or near a timeassociated with a prescription. For example, if the patient is supposedto take a medication once every twenty-four (24) hours and the last timethe cap 584 was opened was yesterday morning at eight (0800), thecompliance module 510 may display a result of a game between seventhirty (0730) and eight thirty (0830) in the morning of the current day.If the patient takes the medicine as directed, the patient will behandling the compliance module 510 and/or the container 582 during thisone-hour period and will accordingly be provided with the game result.Thus, if the game result is a winning one, the patient will be able toclaim the associated prize. If the patient fails to take the medicine asdirected, however, the patient will miss seeing the game resultdisplayed during the one-hour period. Many patients will be motivated toremember to take their medicine as prescribed in order to avoid missingany potentially winning game results.

According to some embodiments, rather than being provided with a prizeor a chance at a prize upon each opening or re-closing of the cap 584,the patient may instead build and/or accrue equity in a chance at aprize, improving a chance at winning a prize, and/or increasing thevalue of an available prize with each opening or re-closing of the cap584 (and/or with each other prescription-compliant action). For example,in one game a patient may win a prize if the patient obtains apredetermined number of occurrences of a particular slot reel symbolover a plurality of game results (e.g., ten cherries). Thus, each timethe patient opens or re-closes the cap 584, the patient is hoping toobtain a game result that includes a cherry. The compliance module 510may be operable to track the number of occurrences of the particularsymbol the patient is attempting to collect. In such an embodiment, thefrequency of the appearance of the symbol the patient is attempting tocollect may change.

For example, the symbol may appear more frequently when the patientfirst begins to collect the symbol, thus encouraging the patient tocomply with a prescription. The probability of “winning” a game mayotherwise generally be fixed, manipulated, and/or managed based onactions taken and/or actions that should be taken (e.g., pursuant to aprescription) by the patient. In the case that the game is bingo and thecompliance module 510 is provided with access to the layout of a bingocard played by the patient, for example, the compliance module 510 maycalculate probabilities based on the layout and bingo numbers alreadyprovided to the patient to determine one or more bingo numbers thatshould currently be provided to the patient. Other games may similarlybe analyzed to determine the game output to be provided to the patient.In some embodiments, the game output may be fixed and/or not dependentupon any particular criteria. The compliance module 510 may, forexample, be preprogrammed to provide a certain fixed sequence of bingonumbers (and/or other game output) to the patient. In some embodiments,these pre-determined numbers may be pre-associated with a “winning”bingo card, and the patient must simply comply with the prescription toobtain the numbers and realize the “win”.

In another example, each time the patient opens or re-closes the cap584, the patient may be provided with a chance to win a progressivejackpot. In some embodiments, the patient may compete with otherpatients for the progressive jackpot. Further, each time the patientopens or re-closes the cap 584 a contribution to the progressive jackpotmay be made, such that the progressive jackpot increases over time.

In yet another example, a discount or other benefit available to thepatient may increase over time as the patient remains compliant,achieves a certain compliance level, and/or is otherwise deemed to beappropriately compliant. For example, a discount in the patient'sinsurance co-pay, insurance deductible, and/or insurance premiums mayincrease by a predetermined amount for each predetermined period of timeover which the acceptable and/or increased compliance is measured. Insuch embodiments the patient may be penalized for not complying with aprescription by, for example, a substantial reduction and/or removal ofsuch a discount. Thus, a patient that has been compliant for an extendedlength of time and has thus earned a substantial discount will be quitemotivated to remain compliant in order to maintain the level of discountthat it took so long to earn and/or accrue.

In some embodiments, the patient may be provided with a chance to win aprize each time the patient opens or re-closes the cap 584 and also, inaddition, be entered into a bonus game and/or pool for a chance to win alarger prize.

In addition to games of chance, the games playable by the patient mayinclude games of skill and/or games that are part chance and part skill.For example, a question game (such as a “trivia” game) may be madeavailable via the compliance module 510. The questions for the game maybe, for example, stored in the memory of the compliance module 510and/or the memory of another computing device (e.g., the user device 140and/or the controller 150) with which the compliance module 510 may beoperable to communicate.

In one example of a question game, the questions may be related to thesubstance stored in the container 582 and/or to a prescriptionassociated with the patient. For example, the patient may be asked(and/or otherwise presented with a question) whether the substancecauses drowsiness, is to be taken with food, can be taken with alcohol,and/or is compatible with another substance. In such question gameembodiments, the compliance module 510 may include an input device (suchas the input device 318; not shown in FIG. 5A or FIG. 5B) via which thepatient may provide answers to the questions.

In some embodiments, one or more questions may be provided to thepatient as a further requirement of claiming a prize. For example,assuming a winning game result has been output to a patient via thecompliance module 510, the patient may be required to visit a Web sitein order to input an indication of the winning result (e.g., anencrypted code output via the second display device 520 b) and claim theassociated prize. However, before the patient is allowed to claim theprize, the patient may be asked one or more questions. Such questionsmay, for example, be related to one or more medicines and/or othersubstances or devices that the patient currently has a prescription,therapy, and/or health care regimen for. In some embodiments, thequestions may simply be trivia questions of any practicable and/ordesirable nature or complexity.

According to some embodiments, questions may be asked of the patient toallow the patient to remediate previous acts of non-compliance. Apatient that misses one or more medication doses, for example, may beable to cure (and/or offset) the defects in compliance by successfullyanswering one or more questions related to the patient's prescription,likely consequences of missing doses, etc. According to someembodiments, the remedial questions may comprise a test or quiz that thepatient must pass (by achieving a certain pre-determined percentage ofcorrect answers) in order to correct partial non-compliance. In someembodiments, the “passing score” required may be determined based on theseverity of previous non-compliance. A patient that has only missed asingle dose may be required to answer one out of five questionscorrectly, for example, while a patient that has missed many doses maybe required to answer ninety to one hundred percent (90-100%) ofquestions correctly. In some embodiments, “correction”, “remediation”,and/or “offset” of non-compliance by answering questions or performingother acts may not “erase” non-compliance (e.g., the statistics of howoften the patient took a medication may remain the same), but maypreserve or recapture the patient's ability to win a prize or obtain areward.

In another example of a type of game that may be played via thecompliance module 510, the output devices 520 a-b of the compliancemodule 510 may output a number or set of numbers that the patient mustmatch to a second number or second set of numbers known to the patient.For example, the patient may win a prize if the number or set of numbersoutput via the compliance module 510 matches the prescription number ofa prescription associated with the patient, the patient's socialsecurity number, and/or the patient's telephone number. Such a numberand/or numbers output via the medicine container may be determinedrandomly, for example, such as in a manner similar to that describedelsewhere herein.

In some embodiments, an input by the patient may be incorporated intothe determination of a game result (e.g., for added user enjoyment andfurther motivation to open the container 582). For example, the exacttime at which the patient opens the medicine container may beincorporated into the determination of the random number used todetermine the game result. For example, in some embodiments, the randomnumber generator may continuously generate random numbers and the randomnumber generated at the time of the cap 584 removal may be the randomnumber used to produce the game result.

While in some embodiments the game results and/or indications of prizesmay be provided to the patient via the compliance module 510 (and/or viaanother user-associated device), in accordance with some embodiments,the patient may be required to contact another entity and/or device(such as the controller 150) to obtain the game results and/or prizeinformation or for further verification that the patient is in factentitled to the prize indicated by the game result. This may be thecase, for example, for prizes with values over a predetermined value(e.g., prizes worth more than twenty dollars). In some embodiments, thepatient may need to provide additional verification and/or validation ofhaving taken the substance as prescribed in order to collect a prize wonbased on a game result. For example, prizes valued above a predeterminedthreshold may require such additional validation of compliance.According to some embodiments, additional validation of compliance maycomprise having the patient provide a code output by the compliancemodule 510, such as the compliance and/or game codes described in detailelsewhere herein.

In another embodiment, a patient attempting to redeem and/or obtain alarge prize may be required to document compliance with a prescriptionby use of reagent test strips and/or other substance detection devices.For example, a patient may be provided with a plurality of reagent teststrips. A test area of each reagent test strip may be impregnated withan appropriate indicator that reacts with a particular substance beingtested for. The substance to be taken by the patient may, according tosome embodiments, be coated with a quick-dissolving coating containingthe substance being tested for. Alternatively, the patient may beprovided with a second set of pills and/or other substances coatedand/or impregnated with the substance being tested for. A syrup and/orother ingestible and/or edible substance that includes the substancebeing tested for may, for example, be provided.

In such embodiments, the patient may be required to ingest the secondpill and/or other substance each time the prescription-related substanceor medicine is taken. When the indicator reacts with the substance beingtested for, a color change of the test area of the reagent test stripmay occur. In such an embodiment, the patient may be required to place atest strip into his mouth after taking the medicine and store the usedtest strips in an appropriate container. If and when the patient obtainsa game result that corresponds to a prize of at least a predeterminedvalue, the patient may be required to provide one or more of the usedtest strips as further proof of having taken the required substance. Inone embodiment, a reagent test strip may be in the shape of a toothpick.

According to some embodiments, testing for a substance and/or reagentmay be accomplished by a toilet and/or other common device outfittedwith testing means. A toilet at a testing facility (e.g., at a patient'splace of business or insurance agency office) may, for example, comprisephysical and/or electronic devices to detect, measure, and/or indicatethe presence of a substance. Such devices may be as simple as anintegrated test strip or indicator area (presumably a refillable and/orreusable area under the rim or in the bowl of a toilet) and/or maycomprise one or more electrodes and a processing device to analyzeelectrode readings. In some embodiments, the effluent from the toiletmay be analyzed by one or more devices coupled to the plumbing leadingaway from the toilet. Such a device may, for example, be easilyretrofitted onto and/or into existing plumbing systems such as thoseaccessible via a basement, crawlspace, and/or utility closet of thepatient, employer, insurer, and/or testing facility.

In one or more embodiments the substance being tested for may include acomponent that degrades or decomposes over time at a predetermined rate,such that a laboratory may be able to determine a length of time since aparticular reagent test strip has been used. For example, a laboratorymay be able to determine whether the patient used the reagent teststrips over time as required or whether all the reagent strips were usedat once (e.g., right before sending them into the laboratory).

In yet another embodiment of how a patient may be required to furthervalidate compliance, the patient may be required to visit a physician orlaboratory for testing to verify that the patient has been taking thesubstance. For example, a physician or laboratory may collect a bloodsample from the patient for analysis to determine whether the correctdosage of the substance is resident within the patient's bloodstream.

In yet another embodiment of how a patient may be required to furthervalidate compliance, the patient may be provided with pills that eachinclude a bar code imprinted thereon. The patient may, according to someembodiments, also be provided with a bar code scanner (and/or a barcodescanner may be incorporated into the compliance module 510). In such anembodiment, the patient may be required to scan the bar code of eachpill before ingesting the pill. If the patient wins a prize (or a prizeof at least a predetermined value), the patient may be required toprovide the data from the bar code scanner to further verify compliance(e.g., by taking the bar code scanner or memory card of the bar codescanner to a pharmacy).

In some embodiments, friends or relatives of a patient may be allowed tofund one or more prizes available to the patient. For example, as abirthday present, a granddaughter may provide one hundred dollars ($100)to an entity to fund prizes for her grandmother (e.g., a patient). Thegranddaughter may even be able to specify how the one hundred dollars($100) is to be provided to her grandmother. For example, thegranddaughter may specify that the one hundred dollars ($100) is to beprovided as one large prize or distributed over a plurality of small,frequent prizes. The granddaughter may also or alternatively be able tospecify conditions upon which the funded prize will or will be likely(e.g., to a certain degree of probability) to be awarded to thegrandmother. The granddaughter may specify, fore example, that thegrandmother must attain a compliance of at least eighty percent ($80%)and/or maintain that level of compliance for one (1) month, in order toqualify for the funded prize. The patient/grandmother may or may not beinformed of the source for the funding of the prize. Friends orrelatives may also or alternatively be allowed to purchase a chance forthe patient to win a relatively large prize. For example, a nephew maypay fifty dollars ($50) to obtain a chance for his aunt (e.g., apatient) to win a one million dollar ($1,000,000) jackpot.

It is understood that some patients may miss a dose of medicineoccasionally. In some embodiments, such occasional misses may be allowedso long as the patients admits to (and/or documents) the miss after itoccurs and before taking the next dose. The compliance module 510 may,for example, track the indication of the miss and the patient'sacknowledgement of the miss before the taking of the next dose. Thecompliance module 510 may incorporate this information in the nextencrypted code and/or game-related output generated for the patient. Insome embodiments, the patient may be provided with an opportunity toperform one or more tasks (e.g., taking a test and/or performingadditional health-related activities) to make up for missed doses. Thecompliance module 510 may also or alternatively provide remedialinstructions to the patient based at least in part on the missed dosage.It may be appropriate to take one medicine as soon as possible after amissed dose, for example, while it may be appropriate to wait until thenext dosage time until taking the next dose of another medicine.Similarly, other missed dosage and/or treatment rules may be associatedwith taking vitamins, dietary supplements, and/or performing therapies.This information may be provided via either or both of the outputdevices 520 a-b, for example.

It should be noted that various rewards and/or benefits for complyingpatients are envisioned, including but not limited to: (i) priorityservicing (e.g., such that patients needn't wait on hold, wait in a lineat a pharmacy, etc.), (ii) information on drug trials (pharmaceuticalcompanies may wish to test drugs with patients who are known to complywith prescriptions, and may pay them for participating), (iii) frequentflyer miles, (iv) prepaid telephone time (e.g., a patient's account isawarded five minutes of phone time for every “success”), (v) premiumentertainment content (e.g., access to pay-per-view television, movies,music, and/or Web sites), (vi) health care and/or medical service (e.g.,doctor's services and/or cosmetic procedures), and/or (vii) cash,discounts, and/or other consideration.

In some embodiments, a benefit for patient compliance may comprise anentry into a sweepstakes or a lottery. For example, a process forproviding a benefit to a patient may comprise the following steps: (i)receiving an encrypted code comprising a patient identifier from apatient, (ii) decrypting the code to determine the patient's compliancewith a prescription, and if the patient is compliant, (iii) entering thepatient identifier in a sweepstakes, (iv) drawing a patient identifierat random, and (v) providing a benefit to the patient associated withthe drawn patient identifier. In some embodiments, a patient'sidentifier may be entered into a sweepstakes more than once. Forexample, a patient may be entered into a sweepstakes once per each“success.” In other embodiments, a patient's number of entries may bebased on the length of time the patient is compliant, the patient's“success percentage,” etc.

Compliance Pad

Turning now to FIG. 6, a perspective cross-sectional diagram of a system600 according to some embodiments is shown. In some embodiments, thesystem 600 (and/or components thereof) may execute, perform, and/or mayotherwise be associated with the method 200 described in conjunctionwith FIG. 2. The system 600 may comprise, for example, the compliancemodule 610 and/or a container 682. The container 682 may comprise a cap684 and/or a label 686. In some embodiments, the compliance module 610may comprise one or more detection areas 692. According to someembodiments, the components 610, 682, 684, 686 of the system 600 may besimilar in configuration and/or functionality to the similarly namedand/or numbered components described in conjunction with any of FIG. 1,FIG. 3, FIG. 5A, and/or FIG. 5B. The compliance module 610 may, forexample, be similar to the compliance modules 110, 310, 510 describedelsewhere herein. In some embodiments, fewer or more components thanthose shown in FIG. 6 may be included in the system 600.

In some embodiments, such as shown in FIG. 6, the compliance module 610may be or include a pressure-sensitive and/or other pad for facilitatingincreased patient compliance with prescriptions, therapies, and/orhealth care regimens. According to some embodiments, such apressure-sensitive and/or otherwise compliance-facilitating device maybe referred to as a “compliance pad” (e.g., a pad-style device that isoperable to track and/or enhance patient compliance). One advantage to acompliance pad 610 is that it may be operable to facilitate compliancewithout requiring substantial and/or any modification to standardmedicine and/or other containers 682 (and/or caps 684 thereof).Electronic components may be substantially housed by and/or incorporatedin the compliance pad 610, for example, while a substantially standardpill bottle and/or other container 682 may be utilized therewith.

In the case that a patient has many prescriptions and/or must takemultiple medications or other substances, for example, the compliancepad 610 may be utilized to easily track compliance with any or all suchhealth care requirements without requiring substantial (or any)modifications to the multiple standard containers 682 used by thepatient to store various health-related substances. The detection areas692 of the compliance pad 610 may comprise one or morepressure-sensitive areas, for example, upon which standard containers682 may be placed. In some embodiments, the compliance pad 610 mayfunction physically as a container stand (e.g., to stabilize and/orotherwise hold or position the container 682), a coaster, a medicinecabinet and/or medicine shelf or drawer liner (or a shelf itself),and/or may otherwise serve as a location to place one or morehealth-related substances and/or devices.

In some embodiments, the compliance pad 610 may comprise a weight, massbalance, and/or motion sensor, such that the compliance pad 610 may beoperable to (i) determine a first mass of the container 682 (includingor not including the cap 684), (ii) detect a first movement and/orremoval of the container 682 from the compliance pad 610, (iii) detect asecond movement and/or a replacement of the container on the compliancepad 610, (iv) determine a second mass of the container 682, and (v)determine a difference between the first and second masses. In such amanner, for example, the compliance pad 610 may measure compliance bythe removal of the container 682 from the compliance pad 610 anddetermining a change in the mass of the container 682 (e.g., indicatingthat an amount or quantity of a substance has been removed there from).According to some embodiments, the detection areas 692 may be or includethe weight, mass balance, motion, and/or other sensors (such as thesensor 314).

In some embodiments, the detection areas 692 may comprise one or moreelectrical contacts and/or other sensors operable to determine whetherthe cap 684 of the container 682 is removed (and/or replaced). Thedetection areas 692 may, for example, comprise a camera, a photocell,and/or a signal generator and/or receiver. A camera may be pointedsubstantially vertically, for example, to capture images looking throughthe bottom of the container 682 toward the cap 684. The images may then,according to some embodiments, analyzed to detect, identify, and/orotherwise determine changes between images that may indicate that thecap 684 is removed, replaced, and/or otherwise manipulated (e.g.,twisted or depressed). A photocell may similarly be directed to collectdata through the bottom of the container 684 to detect changes in lightlevels that may indicate events associated with the cap 684. Signalsand/or beams such as radar, photo-optic, and/or IR beams may also oralternatively be directed through the bottom of the container 682 towardthe cap 684. The reflection, diffraction, and/or other characteristicsof such beams may then be analyzed, for example, to determine if the cap684 is removed, replaced, and/or otherwise manipulated. In someembodiments, such beams may be generated and/or otherwise emanate fromthe cap 684. The detection areas 692 may then, for example, detect thecharacteristics and/or presence of such signal and/or beams to determineif the cap 684 is positioned on top of the container 682.

In some embodiments, the detection areas 692 may also or alternativelycomprise one or more electrical contacts. The container 682 may alsocomprise electrical contacts (not shown), for example, that may coupleto and/or otherwise engage the contacts of the detection areas 692. Theplacement of the container 682 upon a detection area 692 may, forexample, complete a circuit to indicate that the container 682 has beenplaced on the compliance pad 610. According to some embodiments, suchelectrical contacts may also or alternatively indicate whether the cap684 is coupled to the container 682. An electrical contact of the cap684 (also not shown) may, for example, couple to an electrical contactnear the top of the container 682 to complete a portion of acap-detection circuit. This cap-detection circuit may in turn be coupledvia an electrical trace to a contact near the bottom of the container682 that may engage and/or communicate with the detection areas 692 toindicate (i) the presence of the container 682, and/or (ii) the couplingand/or presence of the cap 684. In some embodiments, any or all of theseelectrical contacts and/or traces may be incorporated into thecompliance pad 610, the container 682, and/or the cap 684, and/or may becoupled thereto via any techniques that are or become known orpracticable. Electrical traces of the container 682 may, for example, beincorporated into the label 686, such that a substantially standardcontainer 682 may be easily modified to provide electrical indicationsto the detection areas 692.

According to some embodiments, communication between the container 682,the cap 684, and/or the detection areas 692 may be partially and/orentirely wireless. Passive induction devices may be utilized, forexample, to allow the detection areas 692 to detect the presence and/orproximity of the container 682 and/or the cap 684. In some embodiments,RFID devices may also or alternatively be utilized. Each container 682and/or cap 684 may be equipped with an RFID tag, for example, that iscapable of being either actively or passively detected by the detectionareas 692. Such an RFID tag may indicate various information such as aunique identifier, container 682 and/or cap 684 data, and/orprescription or substance information (e.g., type of substance and/ormedication, expiration date, prescription rules, and/or compatibilitieswith other medications).

Such unique identification information may, according to someembodiments, be utilized by the compliance pad 610 to determine and/orindicate potential incompatibility of substances. In the case that apatient taking multiple medications places two containers 682 on and/ornear the compliance pad 610, for example, the detection areas 692 maydetermine (e.g., via RFID technology) the nature and/or identificationof the medicines that are present. A compatibility table, matrix, and/orother file or data may then be accessed, for example, to determine ifthe two medications may be safely taken together. In the case that aconflict is determined, the compliance pad 610 may alert the patientand/or another entity of the potential danger. In the case thatprescription information is obtained from the container 682, thecompliance pad 610 may also or alternatively provideprescription-specific information to the patient (such as “take one pillwith food daily”, “avoid sunlight”, etc.).

Turning now to FIG. 7, a plan view of a compliance module 710 accordingto some embodiments is shown. In some embodiments, the compliance module710 (and/or components thereof) may execute, perform, and/or mayotherwise be associated with the method 200 described in conjunctionwith FIG. 2. The compliance module 710 may comprise, for example, one ormore input devices 718 a-c, one or more output devices 720 a-c, and/orone or more detection areas 792 a-e. The input devices 718 a-c maycomprise a keypad 718 a, a command button 718 b, and/or directionalcontrols 718 c. The output devices 720 a-c may comprise a display screen720 a, a speaker 720 b, and/or one or more LED devices 720 c. Accordingto some embodiments, the components 718 a-c, 720 a-c, 792 a-e of thecompliance module 710 may be similar in configuration and/orfunctionality to the similarly named and/or numbered componentsdescribed in conjunction with any of FIG. 3, FIG. 5A, FIG. 5B, and/orFIG. 6. In some embodiments, fewer or more components than those shownin FIG. 7 may be included in the compliance module 710.

In some embodiments, the compliance module 710 may be similar inconfiguration and/or functionality to the compliance module 610described in conjunction with FIG. 6. As shown in FIG. 7, for example,the compliance module 710 may be configured as a “compliance pad”. Thecompliance pad 710 may, according to some embodiments, be provided to apatient by an employer, a health care provider, and/or an insuranceentity. The compliance pad 710 may, for example, be associated with oneor more health benefit, discount, and/or study programs associated withoffered by a health insurance carrier. Applicants have realized, forexample, that wellness programs such as the Healthy Rewards® programoffered by CIGNA® may be advantageously supplemented via utilization ofthe compliance pad 710.

Such programs typically incorporate three (3) elements in an attempt topreemptively reduce health care costs. Patients are given incentives,for example, to (i) exercise, (ii) obtain regular physical examinations,and (iii) follow basic nutritional guidelines. The widespread andextremely expensive occurrence of non-compliance with prescriptions,therapies, and/or other health care regimens, however, has continued toprove difficult to address. Utilization of the compliance pad 710 and/orexecution of the various procedures and/or other embodiments describedherein, however, may prove to be an effective fourth element of wellnessprograms that may function to more effectively reduce health care costsand associated health care premiums (e.g., for individuals and companiesalike).

For example, the compliance pad 710 may be or include a pad-like devicethat is provided to insured patients as part of a wellness program. Thecompliance pad 710 may be configured, according to some embodiments, tomonitor patient compliance with a prescription and/or to providegame-related output to entice the patient to increase compliance. Insome embodiments, the compliance pad 710 may be comprised of one or moreflexible mediums such as a flexible Printed Circuit Board (PCB), aflexible LCD, rubber, plastic, and/or other flexible and/orsemi-flexible materials. According to some embodiments, the compliancepad 710 (and/or a portion thereof) may be comprised of foam,visco-elastic foam, glass, aluminum, steel, and/or a fabric such aspolyester. The compliance pad 710 may, for example, be similar incomposition and/or flexibility to a mouse pad. One advantage to aflexible compliance pad 710 may be that it is more easily transported(e.g., it may be rolled-up and/or folded) and/or more easily maintained(e.g., less subject to breakage or damage) than a rigid device. Anyconfiguration of materials, shapes, sizes, and/or flexibilities that areor become desirable may, however, be utilized to define the compliancepad 710.

In some embodiments, the compliance pad 710 may comprise the one or moreinput devices 718 a-c. The compliance pad 710 may comprise, for example,the keypad 718 a, the command button 718 b, and/or the directionalcontrols 718 c. The keypad 718 a may, according to some embodiments,comprise a standard layout of keys such as that utilized on mosttelephones and/or calculators. In some embodiments, the keypad 718 a maybe utilized by a patient to enter information into the compliance pad710. The patient may, for example, be able to configure preferences(e.g., contrast, colors, font, and/or modes) and/or customize thedisplay screen 720 a, enter information (e.g., prescription information,insurance information, and/or patient identification information),provide access codes such as a Personal Identification Number (PIN),and/or otherwise interact or interface with the compliance module 710.In the case that games and/or game interfaces are presented via thedisplay screen 720 a, for example, the patient may be able to utilizethe keypad 718 a to provide game input (e.g., moves, commands, and/orother actions) to the compliance module 710. In other words, the patientmay utilize the keypad 718 a to “play” a game via the compliance pad710.

According to some embodiments, the command button 718 b may also oralternatively be utilized to provide input to the compliance pad 710. Asshown in FIG. 7, for example, the “show code” command button 718 b maybe utilized by the patient to command the compliance pad 710 to show acode (e.g., via the display screen 720 a). The patient may utilize thecommand button 718 b, for example, to cause the compliance pad 710 todisplay a compliance and/or game-related code such as those codesdescribed elsewhere herein. At the end of a compliance period, forexample, the patient may press the command button 718 b to obtain a codethat may be called-in to a health care entity to determine compliance,participate in a game, and/or to qualify for and/or receive prizes orother rewards. Other functionalities of the command button 718 b may, ofcourse, also or alternatively be implemented. The command button 718 bmay be utilized, for example, to obtain a compliance status (e.g.,“complaint” or “non-compliant”, or “70%”) and/or a game status (e.g.,“win!” or “sorry”). In some embodiments, the command button 718 b maynot be included in the compliance pad 710 and/or may be incorporatedinto the keypad 718 a.

In some embodiments, the directional controls 718 c may also oralternatively be included in the compliance pad 710. The directionalcontrols 718 c may, for example, be utilized to providedirection-related input to the compliance pad 710. As shown in FIG. 7,for example, the directional controls 718 c may be utilized to increaseor decrease the volume of the speaker 720 b. Other such input may alsoor alternatively be provided by the directional controls 718 c. Thedirectional controls 718 c may, for example, be utilized to providedirectional input to play a game via the compliance pad 710 and/or tonavigate menus provided via the display device 720 a. Although only twodirectional controls 718 c are shown in FIG. 7, it should be understoodthat fewer (e.g., a single multi-directional pad-style button) or more(e.g., a four-way grouping of controls) directional controls 718 c maybe included in the compliance pad 710.

The output devices 720 a-c may be utilized to provide any of varioustypes of output to the patient (and/or other entities). The displaydevice 720 a may, as shown in FIG. 7 for example, provide indications ofthe time and date, a code, and/or game-related information (e.g., bingonumbers). The code may comprise an encoded and/or encrypted compliancecode indicative of the patient's compliance with a prescription, forexample, while the game-related information may allow the patient toparticipate in a game (e.g., to entice the patient to interact with thecompliance pad 710). Any other types of information that are or becomepracticable may also or alternatively be provided via the display screen720 a. The display screen 720 a may, for example, be utilized to providea game interface such as a slot machine, video game, and/or trivia gameinterface.

According to some embodiments, the speaker 720 b may also oralternatively be utilized to provide information to the patient (and/oranother entity such as a pharmacist). The speaker 720 b may, forexample, provide audible and/or spoken commands and/or alerts to thepatient, such as “time to take medicine”, “warning—incompatiblemedicines!”, “game time!”, “please call-in the code”, and/or “you havewon!”. The speaker 720 b may, according to some embodiments, be utilizedin conjunction with the display device 720 a. In the case that thedisplay device 720 a provides and/or renders a game or game interface,for example, the speaker 720 b may provide coordinated and/or attendantsounds and/or other audible game output. In some embodiments, the volumeof the speaker 720 b may be controlled via the directional controls 718c.

The compliance pad 710 may also or alternatively comprise the LEDdevices 720 c. The LED devices 720 c may, for example, be utilized toprovide visual indications to a patient and/or other entity. A green LEDdevice 720 c may indicate current compliance, for example, and/or a redLED device 720 c may indicate non-compliance and/or an error (e.g., lowbattery). A combination of different colored LED devices 720 c (such asshown in FIG. 7) may be utilized to provide many and/or more complexsignals and/or output. The LED devices 720 c may be blinked and/orpulsed at various rates, in succession, in alternating succession,and/or may otherwise be activated, for example, to indicate any of avariety of practicable information. According to some embodiments, oneor more LED devices 720 c may be provided for each detection area 792a-e. A green LED device 720 c adjacent to a detection area 792 a-e mayindicate, for example, that a container is currently detected by thecompliance pad 710 (e.g., via that particular detection area 792 a-e),while a red LED device 720 c and/or an inactive LED device 720 c mayindicate that no container is currently detected via the detection area792 a-e.

In some embodiments, the detection areas 792 a-e may be similar inconfiguration and/or functionality to the detection areas 692 describedin conjunction with FIG. 6. The detection areas 792 a-e may, forexample, comprise pressure-sensitive areas of the compliance pad 710.Any or all of the detection areas 792 a-e may, according to someembodiments, comprise any type or configuration of sensor and/ordetector that is or becomes known or available. In some embodiments,substantially an entire surface (such as the upper surface) of thecompliance pad 710 may be pressure-sensitive. The detection areas 792a-e may accordingly be designated areas of the pressure-sensitivecompliance pad 710. The keypad 718 a and/or other input devices 718 a-cmay also or alternatively be incorporated as designated areas upon suchas pressure-sensitive compliance pad 710. According to some embodiments,the detection areas 792 a-e may comprise one or more undesignated and/orunassigned areas. The surface of the compliance pad 710 may besubstantially unmarked and/or unassigned, for example, and a patient maysimply place containers anywhere upon the surface to activate a singledetection area 792. In some embodiments, such as shown in FIG. 7,multiple distinctly designated and/or marked detection areas 792 a-e maybe provided.

The detection areas 792 a-e may be utilized to detect, track, weigh,and/or otherwise monitor or manage containers placed thereon. Somedetection areas 792 a-d may be configured and/or marked to monitor pillbottles and/or liquid vials, for example, while other detection areas792 e may be configured to monitor pill boxes, food containers, and/orother rectangular objects. Other configurations of detection areas 792a-e may also or alternatively be utilized. An “open” detection area withno distinct internal boundaries (such as described above) and/or otherareas designed to accommodate bags and/or particular types of medicaldevices may also or alternatively be utilized, for example.

In some embodiments, the detection areas 792 a-d may be configured toprovide output. In the case that multiple prescriptions and/orcontainers are to be monitored by the compliance pad 710, for example,it may be desirable to be able to separately and/or distinctly identifywhere each such container should be placed. The first and seconddetection areas 792 a-b are shown as being numbered, for example, tofacilitate patient placement and/or organization of containers. Suchnumbers may be printed on the surface of the compliance pad 710, forexample, and/or may be displayed dynamically via embedded LCD and/or LEDdevices. As shown with respect to the third detection area 792 c,color-coding may also or alternatively be utilized. The patient may beprovided with prescription vials of various colors and/or with variouscolored labels, for example, and the detection area 792 c may becolor-coded to correspond to one or more of the particular containers.Such color-coding may be printed directly on the compliance pad 710and/or may be indicated by one or more lights such as color LED or LCDdevices. In some embodiments, a name and/or other identifier of aparticular medicine may be displayed. As shown with respect to thefourth detection area 792 d, for example, the name “aspirin” may bedisplayed to indicate that an “aspirin” container should be placed onthe fourth detection area 792 d.

According to some embodiments, the output-configured detection areas 792a-d may also or alternatively be utilized to provide game-relatedfunctionality. Games such as “Simon says” and/or other color, pattern,and/or repetition games may be played via variably coloredtouch-sensitive detection areas 792 a-e, for example. In someembodiments, the patient may be prompted to re-arrange variouscontainers as indicated by the detection areas 792 a-e and/or mayotherwise be prompted to undertake actions of skill or timing as part ofa game. In the case that prizes or rewards are available for obtainingsuccessful game results, such games may greatly increase the interest intaking medication and participating in the attendant games provided bythe compliance pad 710.

Controller Method

Referring now to FIG. 8, a flow diagram of a method 800 according tosome embodiments is shown. In some embodiments, the method 800 may beperformed and/or implemented by and/or otherwise associated with thecontroller 150 described in conjunction with FIG. 1. According to someembodiments, the method 800 may begin at 802 by receiving a codeassociated with a patient, wherein the code includes encoded informationthat is indicative of an occurrence of an event associated with thetaking of a substance by a patient. According to some embodiments, thecode and/or information may be recorded on a smart card and/or otherstorage medium and physically delivered to an entity for processing. Insome embodiments, a patient may receive such a code from a compliancedevice such as the compliance modules 110, 310, 510, 610, 710 describedherein, and may call a number associated with a health care providerand/or insurer of the patient. The compliance module and/or pad may, forexample, be provided to the patient by a health care provider, employer,insurance provider, and/or other entity (such as an entity that operatesthe controller and/or performs the method 800).

The patient may then, for example, provide a verbal and/or otherindication of the code (e.g., input via a telephone keypad) to acontroller and/or other receiving device or entity. In some embodiments,an Interactive Voice Response Unit (IVRU) associated with an insurancecarrier and/or a third-party may, for example, receive the code from thepatient. The code may include information indicative ofprescription-related statistics associated with the patient (e.g., anumber of cap removals, amount of substance taken, or other patientactions) and/or may include an indication of a status and/ordetermination of compliance (e.g., such as in the case that a compliancemodule is provided with prescription-related conditions). The codeand/or information may also comprise time stamps, patient, compliancemodule, and/or account identifiers, tamper flags, and/or other suchinformation. According to some embodiments, the code may also oralternatively comprise information indicative of game output and/orresults.

The code and/or encoded information may, for example, indicate that thepatient has won a game (e.g., associated with a compliance module). Thepatient may be provided with a game board such as a Monopoly®,battleship, minesweeper, bingo, card game, and/or other game board, forexample, and the code and/or encoded information may be indicative of aresult and/or action associated with the game. In some embodiments, suchas in the case that the received information indicates that the patientis the winner of a game, the patient may be awarded and/or provided witha prize. According to some embodiments, the code itself may indicate aparticular prize that the patient has won (and/or earned by beingcompliant).

According to some embodiments, the patient and/or compliance module maybe actively solicited for the code. From the patient's perspective inother words, the utilization and/or application of the informationgenerated by a compliance module may be a substantially passive process(e.g., requiring little or no input or intervention on the part of thepatient). The controller may, for example, initiate a communicationsession with the patient such as by placing a phone call and/or sendingan e-mail. This may occur, for example, at the end of a pre-designatedcompliance period, such as at the beginning or end of every month. Anautomated voice system may, in some embodiments, prompt the patient forthe code. An operator and/or other device or entity may also oralternatively request the code from the patient and/or from thecompliance module. A response to the query may then be received. Thepatient may enter the code via a touchtone telephone keypad, for exampleand/or speak the code into the telephone receiver.

In some embodiments, the method 800 may continue by decoding the code todetermine the information, at 804. Various decoding and/or decryptingalgorithms may be used, for example, to determine the encodedinformation based upon the received code. In some embodiments, differentdecoding and/or decrypting algorithms may be utilized for codes receivedfrom different patients and/or different compliance modules. Accordingto some embodiments, other information may be received (e.g., at 804) inaddition to the code itself. A public key and/or other decoding,identification, or routing information may, for example, be received andutilized to facilitate decoding or other processing of the code.

In some embodiments, the controller may retrieve decoding processinstructions from a data storage device and then execute theseinstructions to decode the received data in order to derive one or moreparameters indicative of the decoded data. According to someembodiments, such as in the case that the data is encoded by calculatinga hash value associated with the data, the controller may execute thedecoding process instructions to apply the same hash algorithm to thedata to determine the associated hash value. If the two hash values arethe same, the data may, for example, be authenticated. In someembodiments, the controller may additionally determine whether apositive tamper indication is present. Although this determination maybe effected in a number of conventional ways, in the some embodiments,the determination may be made based on a tamper flag decoded from thereceived information. In the case that the controller determines thattampering is evident, the controller may store an indication of suchtampering in a database such as the data tables described elsewhereherein.

According to some embodiments, the result of decoding may be provided tothe patient, providing immediate feedback as to the receipt, content,and/or effect of the compliance and/or game data. This output may beprovided, for example, in audio form via an IVRU and/or operator or viaother electronic means (e.g., e-mail). The controller may additionallyupdate stored patient data based on the decoded information. Forexample, a patient record may be flagged to indicate that the patienthas tampered with a compliance module and/or that data associated withthe patient has been received.

It should be noted that a code may be not be encrypted, but scrambled insome other manner (e.g., the sum of all the digits of the code isdetermined to be less than ten, and the code is therefore valid).According to some embodiments, a code may be expressed as and/orconverted to a non-human-readable form (e.g., a three-dimensionalbarcode) without requiring any other form of disguise and/or encryption.In some embodiments, codes may not be encrypted, scrambled, encodedand/or otherwise secured at all. A code may, for example, simplycorrelate to a result stored by the controller that other entities (suchas the patient) may be unable to find meaning in without access to thestored cross-reference table.

In some embodiments, the method 800 may continue at 806 by determiningwhether the occurrence of the event is compliant with a conditionassociated with the taking of the substance. The controller 150 may, forexample, analyze the decoded information to determine a complianceassociated with a patient. In some embodiments, the actual compliancemay already have been calculated and/or determined (e.g., by acompliance module) and the controller may simply need to identify suchresults within the decoded information. According to some embodiments,such as in the case that the information contains indications of actionstaken by a patient, the actions may be compared to various prescriptionconditions to determine levels of compliance. In some embodiments,receipt of appropriately coded information may itself be deemed a“compliant” event, such as in the sense that by simply allowing thecontroller to monitor the patient's actions, the patient has beencomplaint.

According to some embodiments, the patient (and/or another entity) maybe provided with a compliance report. Upon determining patientcompliance and/or upon the expiration of a pre-determined compliancetime period, for example, a report may be generated to indicate (i)current compliance status, (ii) compliance history (e.g., during thecompliance period and/or compared to previous compliance periods), (iii)compliance goals, (iv) suggestions for improving compliance, (v) rewardsand/or prizes won or available (e.g., due to achieved compliance), (vi)encouragement messages from family and/or friends, (vii) competitioninformation (e.g., ranks and/or standings of a patient and all othermembers of a certain group), and/or (viii) other compliance orpatient-related information. Such a report may be very advantageous inanalyzing a patient's compliance. The patient, the patient's health careprovider (e.g., doctor or nurse), the patient's insurer, and/or athird-party analysis entity may, for example, utilize the compliancereport to manage and/or increase compliance, distribute benefits orrewards, and/or study or analyze health care statistics.

The method 800 may continue at 808, for example, by providing, in thecase that compliance with the condition is determined, one or morerewards to the patient. The patient may be provided, for example, withone or more benefits based on a number of recorded successes (e.g.,instances of compliant events), a percentage of recorded successes,and/or a ratio of recorded successes to recorded failures (e.g., acompliance percentage). The code received by the patient from thecompliance module (and decoded and/or processed by the method 800) may,according to some embodiments, be used to redeem one or more benefits.For example, a patient acquiring one hundred (100) consecutive successesmay be provided with a code that may be entered into a Web site toachieve a discount on goods or services offered by the Web site.According to some embodiments, the rewards may comprise one or moretrophies, plaques, certificates, badges, medals, and/or other insigniaand/or indications of achievement (e.g., a hat or shirt that says “HappyValley Nursing Home's Best Pill-taker!” or a plaque that shows “Joggerof the Month: April, 2005”).

In another example, a patient may be provided with a code entitling thepatient to a number of entries in a sweepstakes. For example, for everyfive successes, the patient may be provided with an encrypted code,which the patient may “call in” to a sweepstakes telephone servicecontroller. Alternately, at the end of every month, a patient may beprovided with a number of benefits (e.g., sweepstakes entries and/orlottery tickets or numbers) based on a compliance percentage (e.g., thenumber of successes divided by the number of elapsed time periods). Inone embodiment, the value of a benefit (e.g., discount amount, orsweepstakes jackpot) may increase relative to the number of a patient'ssuccesses.

According to some embodiments, the reward given to a patient may bedetermined based at least in part on the compliance of other patients.Patients may compete, for example, to obtain higher compliance ratings,with the most-compliant patient and/or patients receiving a reward orprize. Groups of patients may also or alternatively compete together toobtain rewards. Nursing home and/or other groups of patients may attemptto achieve group compliance goals, for example, to obtain a reward forthe nursing home and/or for another associated third-party such as acharity. According to some embodiments, compliance results may beavailable to competing patients such that patients may be more likely toview the current standings and attempt to achieve higher compliance tooutperform other patients and receive rewards. Such compliance “races”may be quite useful in giving patients a competitive reason to increaseprescription compliance.

In one or more embodiments, a benefit may comprise a set of lotterynumbers. For example, so long as a patient is compliant, the patient maybe provided with several numbers every week for a state-drawn lottery.The numbers may be output, for example, via an output device associatedwith the compliance module. In one example, an LED screen may depictfive lottery numbers, as well as the date/time of the drawing and anencrypted code, which represents the date and the lottery numbersdisplayed to the patient. Should the numbers be winners, the patient mayprovide the encrypted code to a lottery agent so that the claim towinnings may be validated. In another example, a medicine container mayfurther comprise or be associated with a printer that may function toprint a physical lottery ticket.

In one or more embodiments, the patient may be allowed to select theirown lottery numbers for a drawing. For example, in one embodiment thecompliance module may output a code whenever the patient is eligible foran entry into a lottery drawing. The patient may use the code to accessa Web site, via which the patient may select a set of lottery numbers.The Web site may first decrypt the code (e.g., at 804) to verify thatthe patient is in fact eligible to select the set of lottery numbers. Inanother example, a patient may provide a set of preferred lotterynumbers to the compliance module and/or to another entity (e.g., apharmacist may download the selected numbers to the compliance module orthe patient may register, with the controller, the selected set ofnumbers as associated with the patient via a Web site or otherconnection). In this latter example, whenever the patient is eligible tobe entered into a lottery drawing, the patient may be provided with acode. The patient may then call in this code to the controller and/orinput the code into a Web site in order to have the preferred set oflottery numbers automatically entered into the next available lotterydrawing. Alternatively, the compliance module may be operable (e.g., viaa modem) to communicate with the controller whenever the patient becomeseligible for an entry into a lottery drawing, in order to transmit tothe controller an indication of the patient's eligibility. Uponreceiving such an indication, the controller may automatically enter thepatient's preferred set of lottery numbers into the next availablelottery drawing.

In or more embodiments, a compliance module may comprise a random numbergenerator. In one such embodiment, each cap removal and/or otherprescription-related event might trigger the generation of a randomnumber. A benefit may then be awarded based on a result associated withthe random number (e.g., “You've won a Ford® Explorer™! Call1-800-555-5555 and enter code 205034059”). In one embodiment, the randomnumber itself may be displayed to the patient. The patient may thendetermine the result associated with the random number by calling anentity such as the controller 150 with the random number and/or byvisiting a Web site that displays the results associated with variousrandom numbers. In another embodiment, the result associated with therandom number may be displayed via an output device associated with thecompliance module.

The data table comprising a list of random numbers and theircorresponding results may be stored in a memory of the compliance moduleand/or another processor responsive to instructions from the compliancemodule. For example, the data table may be stored in the memory of acomputing device (e.g., the user device 140 onto which appropriatesoftware including the table has been loaded) and the compliance modulemay include an IR and/or RF-based output device via which the computingdevice may be instructed to access the table and display the resultassociated with the random number. In another example, the patient maymanually enter the random number into a computing device (e.g., thepatient's PC or PDA onto which appropriate software including the tablehas been loaded), thus causing the computing device to display theresult to the patient.

It should be noted that a “result” may comprise a representation orindication of a benefit to be provided to the patient. For example, aresult may comprise a slot machine like collection of graphical symbols(e.g., cherry-cherry-cherry). A data table may store a plurality ofavailable results and the benefit (if any) associated with eachrespective result. This data table may be stored, for example, within amemory of the compliance module, within the memory of another computingdevice (e.g., the user device 140 onto which appropriate softwareincluding the table has been loaded), and/or the memory of thecontroller 150.

In some embodiments, historical patient data may provide the basis forrewards or penalties, and could serve as a basis for making pricingdecisions for future insurance coverage. Patients might be provided withhigher reimbursement levels for drugs for which they had complied withthe prescription instructions. For example, a patient might pay onehundred ($100) for a prescription, with the insurance providerreimbursing one quarter (¼) of that amount if the patient does notcomply with the prescription requirements, and one half (½) of thatamount if the patient does comply with the requirements. Insurancecompanies might also require that the patient call in with encoded databefore any reimbursements are provided.

It should also be recognized that a compliance module may includeprocessing instructions to store compliance statistics associated with apatient, and may output an encoded code only upon reaching apredetermined reward threshold. Thus, encoding process instructionscould include code that outputs encoded data only when the patient opensan associated pill or other container a number of times equal to thenumber of doses stored within the container.

In some embodiments, a pharmaceutical supplier may offer rebates topurchasers of pharmaceuticals based on compliance and/or usage (e.g., asindicated by the encoded information). A physician may also oralternatively provide a money back guarantee provided that a patientconforms to a prescription for a specified period of time. In yetanother application of some embodiments, a medical service provider suchas a doctor, health maintenance organization and/or insurance companymay offer preferred rates to their clients who consistently followprescription instructions. By employing such embodiments, any medicalservice provider may easily, accurately, and securely verifyprescription compliance.

Controller

Turning to FIG. 9, a block diagram of a controller 950 according to someembodiments is shown. In some embodiments, the controller 950 may besimilar in configuration and/or functionality to the controller 150described in conjunction with FIG. 1. The controller 950 may, forexample, be utilized to receive patient compliance and/or gameinformation to provide rewards to patients. The controller 950 may alsoor alternatively execute, process, and/or otherwise be associated withthe method 800 described in conjunction with FIG. 8. In someembodiments, the controller 950 may comprise a processor 952, an IVRU954, a communication device 956, an input device 958, an output device960, and/or a data storage device 962. According to some embodiments,the data storage device 962 may store decoding process instructions 964,game instructions 966, decoding data 970, patient data 972, and/or gamedata 974. In some embodiments, fewer or more components, instructions,and/or data than are shown in FIG. 9 may be included in the controller950.

According to some embodiments, the processor 952 may be or include anytype, quantity, and/or configuration of processor that is or becomesknown. The processor 312 may comprise, for example, an Intel® IXP 2800network processor or an Intel® XEON™ Processor coupled with an Intel®E7501 chipset. In some embodiments, the processor 952 may comprisemultiple inter-connected processors, microprocessors, and/ormicro-engines. According to some embodiments, the processor 952 (and/orthe controller 950 and/or other components thereof) may be suppliedpower via a power supply (not shown) such as a battery, an AlternatingCurrent (AC) source, a Direct Current (DC) source, an AC/DC adapter,solar cells, and/or an inertial generator. In the case that thecontroller 950 comprises a server such as a blade server, necessarypower may be supplied via a standard AC outlet, power strip, surgeprotector, and/or Uninterruptible Power Supply (UPS) device.

The IVRU 954 may, according to some embodiments, comprise one or moredevices and/or coded instructions (e.g., software or firmware) capableof performing automated and/or substantially automated communicationswith one or more patients and/or other entities The IVRU 954 maycomprise, for example, a software package such as SpeechWorks® CallNavigator™ powered by SpeakFreely® natural language technology, offeredby ScanSoft® of Burlington, Mass. According to some embodiments, theprocessor 952 may receive signals from the IVRU 954. The IVRU 954 may,for example, receive telephone calls and/or input from one or morepatients. In some embodiments, the IVRU 954 may receive informationindicative of compliance and/or game-related codes supplied to thepatients by compliance modules, and/or may provide such information tothe processor 952. According to some embodiments, the IVRU 954 may alsoor alternatively initiate calls and/or other communications with apatient. The IVRU 952 may, for example, initiate a call to a patient tosolicit and/or request a compliance and/or game-related code (e.g.,provided to the patient by a compliance module).

In some embodiments, the communication device 956 may comprise any typeor configuration of communication device that is or becomes known orpracticable. The communication device 956 may, for example, comprise aNIC, a telephonic device, a cellular network device, a router, a hub, amodem, and/or a communications port or cable. In some embodiments, thecommunication device 956 may be coupled to provide communications accessto the IVRU 954. The IVRU 954 may, for example, execute telephone and/orother voice or data communications with one or more patients via thecommunication device 956. According to some embodiments, thecommunication device 956 may also or alternatively be coupled to theprocessor 952. The communication device 956 may, for example, comprise aseparate device from the IVRU 954. The communication device 956 may, forexample, comprise an IR, RF, Bluetooth™, and/or Wi-Fi network devicecoupled to facilitate communications between the processor 952 andanother device (such as a compliance module).

In some embodiments, the input device 958 and/or the output device 960may comprise any types or configurations of input and output componentsand/or devices that are or become known, respectively. The input device960 may comprise, for example, a keyboard that allows an operator of thecontroller 950 to interface with the controller 950 (e.g., to program,monitor, and/or initiate IVRU 954 sessions). In some embodiments, theinput device 958 may comprise a smart card and/or magnetic stripe cardreader. The input device 958 may, for example, allow a patient and/orpharmacist to swipe a card associated with a patient (e.g., a smartand/or magnetic stripe insurance card) to provide information such asencoded compliance and/or game-related information to the controller 950and/or the processor 952. The output device 960 may, according to someembodiments, comprise a display screen and/or other practicable outputcomponent and/or device. The output device 960 may, for example, providefeedback to the patient or pharmacist that swipes a smart and/ormagnetic stripe card via the input device 958. According to someembodiments, the input device 958 and/or the output device 960 may besimilar in configuration and/or functionality to the input device 318and/or the output device 320 described in conjunction with FIG. 3herein.

The data storage device 962 may, for example, store the decoding processinstructions 964 and/or the game instructions 966 that may be utilizedby the processor 952 to provide output information via the output device958, the IVRU 954, and/or the communication device 956. The data storagedevice 962 may comprise any appropriate information storage device thatis or becomes known or available, including, but not limited to, unitsand/or combinations of magnetic storage devices (e.g., a hard diskdrive), optical storage devices, and/or semiconductor memory devicessuch as Random Access Memory (RAM) devices, Read Only Memory (ROM)devices, Single Data Rate Random Access Memory (SDR-RAM), Double DataRate Random Access Memory (DDR-RAM), and/or Programmable Read OnlyMemory (PROM).

According to some embodiments, the decoding instructions 964 may beoperable to cause the processor 952 to decode information. Informationreceived from any of the IVRU 954, the communication device 956, and/orthe input device 958 may, for example, be decoded by the processor 952in accordance with the decoding instructions 964. In some embodiments,encoded compliance and/or game-related information may be received froma patient and/or compliance module, for example, and may be decoded bythe processor 952 executing the decoding instructions 964. While anydecoding and/or decryption protocol that is or becomes known orpracticable may be utilized to decode the information, in someembodiments it may be desirable to employ the same and/or a similarprotocol that was utilized to encode the information (e.g., by acompliance module). In some embodiments, the data decoded by theprocessor 952 (e.g., utilizing the decoding process instructions 964)may comprise prescription compliance information. The number of cap,top, and/or lid removals in a given time period may, for example, bedecoded by the processor 952. According to some embodiments, other datamay also or alternatively be decoded. Examples of other data may includeuser identifiers, cap and/or container identifiers, insuranceidentifiers, account identifiers, compliance module identifiers, abeginning timestamp and an ending timestamp.

In some embodiments, the game instructions 966 may be operable to causethe processor 952 to execute and/or otherwise process data in accordancewith one or more games. A patient may interface with the controller 950(e.g., via the IVRU 954, the communication device 965, and/or the inputdevice 958) to play a game. Access to such a game may be offered, forexample, by a compliance module in the case that the patient complieswith a prescription-related event and/or achieves some particularcompliance goal. In some embodiments, as described elsewhere herein, thecompliance module may provide the patient with a telephone number and/orUniform Resource Locator (URL) or other address via which the patientmay access the controller 950 to play the game. The processor 952 maythen execute the game instructions 966 to provide and/or render the gamefor the patient. In some embodiments, the controller 950 may also oralternatively receive game-related information such as an encoded gamecode from the patient and/or compliance module. The information may bedecoded by the processor 952 (e.g., executing the decoding instructions964), for example, and then utilized to determine on or moregame-related events and/or outcomes.

A code received from a patient may trigger a particular game result, forexample, and/or may indicate that the patient is eligible for and/or haswon a particular prize. According to some embodiments, the patient mayplay the game via the compliance module and/or another device (e.g., anassociated online game) and may provide a “win” code associated with thepatient's performance. The processor 952 may then, for example, executethe game instructions 966 to process the code and determine a resultassociated with the patient's performance achieved in playing the game.According to some embodiments, the game instructions 966 may simplydirect the patient and/or the controller 950 to one or more otherdevices or Web sites associated with playing or downloading games.

The data storage device 962 may also or alternatively store the decodingdata 970, the patient data 972, and/or the game data 974. Any or all ofthese and other types of data may be stored in any number, type, and/orconfiguration of data storage structures (such as the data storagestructures described elsewhere herein) that is or becomes known. Thedata storage device 962 may, for example, comprise one or more datatables or files, databases, table spaces, registers, and/or otherstorage structures. In some embodiments, multiple databases and/orstorage structures (and/or multiple data storage devices 962) may beutilized to store information associated with the controller 950.According to some embodiments, the data storage device 962 may beincorporated into and/or otherwise coupled to the controller 950 (e.g.,as shown) or may simply be accessible to the controller 950 (e.g.,externally located and/or situated).

The decoding data 970 may comprise data associated with decodinginformation via the decoding process instructions 964. The decoding data970 may comprise, for example, one or more hash values, decryption keys,codes, and/or decoding or decryption algorithms. In some embodiments,the patient data 972 may also or alternatively be stored in the datastorage device 962. The patient data 972 may comprise, for example, dataassociated with patients and/or prescriptions, therapies, and/or otherhealth care regimens associated with patients. According to someembodiments, the patient data 972 may comprise patient contactinformation, patient account information, medication data, and/or otherpatient-related information such as a history of prizes or other rewardswon or achieved by patients.

The game data 974 may comprise any game-related data that is or becomesknown or practicable. The game data 974 may, for example, include dataindicative of one or more game boards (e.g., bingo boards, battleshipboards, minesweeper boards), card decks (and/or shoes), maps, and/orother game objects. The game data 974 may also or alternatively includeone or more moves, actions, values, results, outcomes, pay tables,probability tables, and/or other metrics associated with one or moregames. In some embodiments, the game data 974 may comprise one or morefiles such as picture, sounds, movie, and/or other audio or video files.According to some embodiments, the game data 974 may be utilized by theprocessor 952 in executing the game instructions 966. The processor 952may load one or more lottery and/or bingo numbers from the game data974, for example, to be provided to a complaint patient. These and otheraspects of the various types of stored data according to someembodiments are described in more detail with reference to FIG. 10A,FIG. 10B, and FIG. 10C.

Controller Data Tables

Referring now to FIG. 10A, FIG. 10B, and FIG. 10C, block diagrams ofdata tables 1070, 1072, 1074 according to some embodiments are shown,respectively. In some embodiments, the data tables 1070, 1072, 1074 maybe similar in configuration and/or content to the data 970, 972, 974and/or data tables described in conjunction with FIG. 9. Any or all ofthe data tables 1070, 1072, 1074 may, for example, be stored in and/orotherwise associated with the controller 150, 950. According to someembodiments, a decoding data table 1070 may store decoding-relatedinformation, a patient data table 1072 may store information associatedwith patients, and/or a game data table 1074 may store game-relatedinformation, for example. In some embodiments, fewer or more data fieldsthan are shown may be associated with the data tables 1070, 1072, 1074.Only a portion of one or more databases and/or other data stores isnecessarily shown in any of FIG. 10A, FIG. 10B, and/or FIG. 10C, forexample, and other database fields, columns, structures, orientations,quantities, and/or configurations may be utilized without deviating fromthe scope of some embodiments. Similarly, the data shown in the variousdata fields is provided solely for exemplary and illustrative purposesand does not limit the scope of embodiments described herein.

According to some embodiments, such as shown in FIG. 10A for example,the decoding data table 1070 may comprise various data fields such as a“compliance_module_id” field 1070-1, a “patient_id” field 1070-2, and/ora “key” 1070-3. The “compliance_module_id” field 1070-1 may, forexample, simply store an identifier for each compliance module that isissued and/or monitored by and/or otherwise associated with thecontroller 150, 950. Each compliance module (such as a compliance pad)may, for example, be represented by a unique identifier such as analphanumeric code stored in the “compliance_module_id” field 1070-1.Each compliance module may also be associated with one or more patientsrepresented by the “patient_id” field 1070-2. In such a manner, forexample, compliance modules may be accurately associated with particularpatients (and vise versa). The “key” field 1070-3 may contain one ormore cryptographic and/or other decoding keys, hash values, metrics,and/or algorithms. Such information may be utilized (e.g., via thedecoding process instructions 964) to decode and/or decrypt informationreceived from a compliance module and/or an associated patient.Different cryptographic information (e.g., public and/or private keys)may be stored for different compliance modules and/or patients, ormultiple compliance modules and/or patients may be associated withstandardized and/or universal cryptographic information.

According to some embodiments, such as shown in FIG. 10B for example,the patient data table 1072 may comprise various data fields such as a“patient_id” field 1072-1, a “phone” field 1072-2, an “insurance_id”field 1072-3, a “condition_id” field 1072-4, a “tamper” field 1072-5, a“score” field 1072-6, and/or a “rank” field 1072-7. The patient datatable 1072 may store information associated with various prescriptions,therapies, health care regimens, identification information, and/orother data associated with patients (e.g., patients participating in awellness program). The “patient_id” field 1072-1 may simply store anidentifier (such as a unique identifier) for each registered patient. Insome embodiments, the “patient_id” field 1072-1 may link to and/or beotherwise associated with the “patient_id” field 1070-2 of the decodingdata table 1070. Contact, identification, and/or demographic informationassociated with patients may be stored in various data fields as isdesirable.

The “phone” field 1072-2 may, for example, store one or more telephonenumbers and/or linking identification information (e.g., linking toother tables such as a telephone number table—not shown) associated witha patient. Other information may be similarly stored and/or linked to.Insurance information (such as a health insurance account number) may berepresented by and/or linked by the information stored in the“insurance_id” field 1072-3, for example. Conditions associated with apatient's prescriptions may also or alternatively be stored and/orlinked to via the patient data table 1072. The “condition_id” field1072-4 may, for example, link to a table (not shown) containinginformation describing conditions of a patient's prescriptions. Thisinformation may be utilized, for example, to determine if eventsassociated with a patient are in compliance with a prescription. In someembodiments, the “condition_id” field 1072-4 may link to an externaltable such as via the “condition_id” field 432-1 of the condition datatable 432 stored in some compliance modules.

According to some embodiments, the “tamper” field 1072-5 may showwhether a compliance module associated with a patient has been tamperedwith (e.g., “Y”=positive tamper indication). In some embodiments, apositive tamper indication associated with a patient via the “tamper”field 1072-5 may disqualify a patient from receiving prizes and/orrewards and/or may cause the patient to be otherwise penalized (e.g.,charged a fee for damaging a compliance module).

In some embodiments, the “score” field 1072-6 may contain information(such as the numeric information shown) indicating a score achieved byand/or otherwise associated with a patient. The score may be a scorerepresenting compliance, for example, or may represent a patient'sachievement in a game associated with facilitating compliance. Accordingto some embodiments, the score may indicate a patient's score withrespect to a competition between patients and/or groups of patients. The“rank” field 1072-7 may, for example, show a ranking (e.g., based on thepatient's score) of competing patients. All patients in a particulargeographical area (e.g., a town, city, state, or zip code), employees ofa particular office, members of a particular insurance carrier, and/ormembers of other pre-defined groups (e.g., Internet groups, clubs,organizations) may, for example, compete for the best compliance (e.g.,as represented by the score in the “score” field 1072-6) to winindividual and/or group prizes. In some embodiments, the scores and/orrankings may be provided to the patients to further motivate increasedcompliance (e.g., by stimulating competitive tendencies).

According to some embodiments, such as shown in FIG. 10C for example,the game data table 1074 may comprise various data fields such as a“game_id” field 1074-1, a “game_name” field 1074-2, “win_code” field1074-3, and/or a “prize” field 10744. The game data table 1074 may storeinformation associated with various games used to facilitate and/orenhance patient compliance with prescriptions. The games may be playedvia a compliance module, a controller, and/or via another device. The“game_id” field 1074-1 may simply store an identifier (such as a uniqueidentifier) for each game, for example, while the “game_name” field1074-2 may store a name of each game. The games shown in FIG. 10C, forexample, are “bingo”, “lotto”, and “minesweeper”. Many other games mayalso or alternatively be stored and/or used as described elsewhereherein.

In some embodiments, the “win_code” field 1074-3 may store one or morecodes and/or other data associated with particular game outputs and/orresults. In the case that the game is a form of video poker played via acompliance module and/or via a controller, for example, a code of“ACE93” may be associated with a particular video poker result. In thecase that this code is received from a patient (and/or decoded viainformation received from a patient), for example, a particular card,hand, and/or outcome may be provided to the patient (e.g., via thecompliance module and/or controller). In some embodiments, the code mayindicate that the patient has “won” the game. A patient having compliedwith prescription requirements may have been presented withopportunities to play a video poker game via a compliance module, forexample, and may have achieved a “winning” result in the game. Thecompliance module may generate a game code and/or an encoded versionthereof and provide the game code to the patient. The patient may thencommunicate the game code to a controller that may decode theinformation and compare the resulting game code to the code stored inthe game data table 1074. In the case of the video and/or other pokergame and received code of “ACE93” shown in FIG. 10C, for example, thematching of the code would indicate that the patient should be awardedone hundred dollars ($100), as stored in the respective “prize” field1074-4 record.

Rules of Interpretation

Numerous embodiments are described in this patent application, and arepresented for illustrative purposes only. The described embodiments arenot, and are not intended to be, limiting in any sense. The presentlydisclosed invention(s) are widely applicable to numerous embodiments, asis readily apparent from the disclosure. One of ordinary skill in theart will recognize that the disclosed invention(s) may be practiced withvarious modifications and alterations, such as structural, logical,software, and electrical modifications. Although particular features ofthe disclosed invention(s) may be described with reference to one ormore particular embodiments and/or drawings, it should be understoodthat such features are not limited to usage in the one or moreparticular embodiments or drawings with reference to which they aredescribed, unless expressly specified otherwise.

The present disclosure is neither a literal description of allembodiments of the invention nor a listing of features of the inventionthat must be present in all embodiments.

Neither the Title (set forth at the beginning of the first page of thispatent application) nor the Abstract (set forth at the end of thispatent application) is to be taken as limiting in any way as the scopeof the disclosed invention(s).

The term “product” means any machine, manufacture and/or composition ofmatter as contemplated by 35 U.S.C. §101, unless expressly specifiedotherwise.

The terms “an embodiment”, “embodiment”, “embodiments”, “theembodiment”, “the embodiments”, “one or more embodiments”, “someembodiments”, “one embodiment” and the like mean “one or more (but notall) disclosed embodiments”, unless expressly specified otherwise.

A reference to “another embodiment” in describing an embodiment does notimply that the referenced embodiment is mutually exclusive with anotherembodiment (e.g., an embodiment described before the referencedembodiment), unless expressly specified otherwise.

The terms “including”, “comprising” and variations thereof mean“including but not limited to”, unless expressly specified otherwise.

The terms “a”, “an” and “the” mean “one or more”, unless expresslyspecified otherwise.

The term “plurality” means “two or more”, unless expressly specifiedotherwise.

The term “herein” means “in the present application, including anythingwhich may be incorporated by reference”, unless expressly specifiedotherwise.

The phrase “at least one of”, when such phrase modifies a plurality ofthings (such as an enumerated list of things) means any combination ofone or more of those things, unless expressly specified otherwise. Forexample, the phrase at least one of a widget, a car and a wheel meanseither (i) a widget, (ii) a car, (iii) a wheel, (iv) a widget and a car,(v) a widget and a wheel, (vi) a car and a wheel, or (vii) a widget, acar and a wheel.

The phrase “based on” does not mean “based only on”, unless expresslyspecified otherwise. In other words, the phrase “based on” describesboth “based only on” and “based at least on”.

The term “whereby” is used herein only to precede a clause or other setof words that express only the intended result, objective or consequenceof something that is previously and explicitly recited. Thus, when theterm “whereby” is used in a claim, the clause or other words that theterm “whereby” modifies do not establish specific further limitations ofthe claim or otherwise restricts the meaning or scope of the claim.

Where a limitation of a first claim would cover one of a feature as wellas more than one of a feature (e.g., a limitation such as “at least onewidget” covers one widget as well as more than one widget), and where ina second claim that depends on the first claim, the second claim uses adefinite article “the” to refer to the limitation (e.g., “the widget”),this does not imply that the first claim covers only one of the feature,and this does not imply that the second claim covers only one of thefeature (e.g., “the widget” can cover both one widget and more than onewidget).

Each process (whether called a method, algorithm or otherwise)inherently includes one or more steps, and therefore all references to a“step” or “steps” of a process have an inherent antecedent basis in themere recitation of the term ‘process’ or a like term. Accordingly, anyreference in a claim to a ‘step’ or ‘steps’ of a process has sufficientantecedent basis.

When an ordinal number (such as “first”, “second”, “third” and so on) isused as an adjective before a term, that ordinal number is used (unlessexpressly specified otherwise) merely to indicate a particular feature,such as to distinguish that particular feature from another feature thatis described by the same term or by a similar term. For example, a“first widget” may be so named merely to distinguish it from, e.g., a“second widget”. Thus, the mere usage of the ordinal numbers “first” and“second” before the term “widget” does not indicate any otherrelationship between the two widgets, and likewise does not indicate anyother characteristics of either or both widgets. For example, the mereusage of the ordinal numbers “first” and “second” before the term“widget”(1) does not indicate that either widget comes before or afterany other in order or location; (2) does not indicate that either widgetoccurs or acts before or after any other in time; and (3) does notindicate that either widget ranks above or below any other, as inimportance or quality. In addition, the mere usage of ordinal numbersdoes not define a numerical limit to the features identified with theordinal numbers. For example, the mere usage of the ordinal numbers“first” and “second” before the term “widget” does not indicate thatthere must be no more than two widgets.

When a single device or article is described herein, more than onedevice or article (whether or not they cooperate) may alternatively beused in place of the single device or article that is described.Accordingly, the functionality that is described as being possessed by adevice may alternatively be possessed by more than one device or article(whether or not they cooperate).

Similarly, where more than one device or article is described herein(whether or not they cooperate), a single device or article mayalternatively be used in place of the more than one device or articlethat is described. For example, a plurality of computer-based devicesmay be substituted with a single computer-based device. Accordingly, thevarious functionality that is described as being possessed by more thanone device or article may alternatively be possessed by a single deviceor article.

The functionality and/or the features of a single device that isdescribed may be alternatively embodied by one or more other deviceswhich are described but are not explicitly described as having suchfunctionality and/or features. Thus, other embodiments need not includethe described device itself, but rather can include the one or moreother devices which would, in those other embodiments, have suchfunctionality/features.

Devices that are in communication with each other need not be incontinuous communication with each other, unless expressly specifiedotherwise. On the contrary, such devices need only transmit to eachother as necessary or desirable, and may actually refrain fromexchanging data most of the time. For example, a machine incommunication with another machine via the Internet may not transmitdata to the other machine for weeks at a time. In addition, devices thatare in communication with each other may communicate directly orindirectly through one or more intermediaries.

A description of an embodiment with several components or features doesnot imply that all or even any of such components and/or features arerequired. On the contrary, a variety of optional components aredescribed to illustrate the wide variety of possible embodiments of thepresent invention(s). Unless otherwise specified explicitly, nocomponent and/or feature is essential or required.

Further, although process steps, algorithms or the like may be describedin a sequential order, such processes may be configured to work indifferent orders. In other words, any sequence or order of steps thatmay be explicitly described does not necessarily indicate a requirementthat the steps be performed in that order. The steps of processesdescribed herein may be performed in any order practical. Further, somesteps may be performed simultaneously despite being described or impliedas occurring non-simultaneously (e.g., because one step is describedafter the other step). Moreover, the illustration of a process by itsdepiction in a drawing does not imply that the illustrated process isexclusive of other variations and modifications thereto, does not implythat the illustrated process or any of its steps are necessary to theinvention, and does not imply that the illustrated process is preferred.

Although a process may be described as including a plurality of steps,that does not indicate that all or even any of the steps are essentialor required. Various other embodiments within the scope of the describedinvention(s) include other processes that omit some or all of thedescribed steps. Unless otherwise specified explicitly, no step isessential or required.

Although a product may be described as including a plurality ofcomponents, aspects, qualities, characteristics and/or features, thatdoes not indicate that all of the plurality are essential or required.Various other embodiments within the scope of the described invention(s)include other products that omit some or all of the described plurality.

An enumerated list of items (which may or may not be numbered) does notimply that any or all of the items are mutually exclusive, unlessexpressly specified otherwise. Likewise, an enumerated list of items(which may or may not be numbered) does not imply that any or all of theitems are comprehensive of any category, unless expressly specifiedotherwise. For example, the enumerated list “a computer, a laptop, aPDA” does not imply that any or all of the three items of that list aremutually exclusive and does not imply that any or all of the three itemsof that list are comprehensive of any category.

Headings of sections provided in this patent application and the titleof this patent application are for convenience only, and are not to betaken as limiting the disclosure in any way.

“Determining” something can be performed in a variety of manners andtherefore the term “determining” (and like terms) includes calculating,computing, deriving, looking up (e.g., in a table, database or datastructure), ascertaining and the like.

It will be readily apparent that the various methods and algorithmsdescribed herein may be implemented by, e.g., appropriately programmedgeneral purpose computers and computing devices. Typically a processor(e.g., one or more microprocessors) will receive instructions from amemory or like device, and execute those instructions, therebyperforming one or more processes defined by those instructions. Further,programs that implement such methods and algorithms may be stored andtransmitted using a variety of media (e.g., computer readable media) ina number of manners. In some embodiments, hard-wired circuitry or customhardware may be used in place of, or in combination with, softwareinstructions for implementation of the processes of various embodiments.Thus, embodiments are not limited to any specific combination ofhardware and software

A “processor” means any one or more microprocessors, CPU devices,computing devices, microcontrollers, digital signal processors, or likedevices.

The term “computer-readable medium” refers to any medium thatparticipates in providing data (e.g., instructions) that may be read bya computer, a processor or a like device. Such a medium may take manyforms, including but not limited to, non-volatile media, volatile media,and transmission media. Non-volatile media include, for example, opticalor magnetic disks and other persistent memory. Volatile media includeDRAM, which typically constitutes the main memory. Transmission mediainclude coaxial cables, copper wire and fiber optics, including thewires that comprise a system bus coupled to the processor. Transmissionmedia may include or convey acoustic waves, light waves andelectromagnetic emissions, such as those generated during RF and IR datacommunications. Common forms of computer-readable media include, forexample, a floppy disk, a flexible disk, hard disk, magnetic tape, anyother magnetic medium, a CD-ROM, DVD, any other optical medium, punchcards, paper tape, any other physical medium with patterns of holes, aRAM, a PROM, an EPROM, a FLASH-EEPROM, any other memory chip orcartridge, a carrier wave as described hereinafter, or any other mediumfrom which a computer can read.

Various forms of computer readable media may be involved in carryingsequences of instructions to a processor. For example, sequences ofinstruction (i) may be delivered from RAM to a processor, (ii) may becarried over a wireless transmission medium, and/or (iii) may beformatted according to numerous formats, standards or protocols, such asBluetooth™, TDMA, CDMA, 3G.

Where databases are described, it will be understood by one of ordinaryskill in the art that (i) alternative database structures to thosedescribed may be readily employed, and (ii) other memory structuresbesides databases may be readily employed. Any illustrations ordescriptions of any sample databases presented herein are illustrativearrangements for stored representations of information. Any number ofother arrangements may be employed besides those suggested by, e.g.,tables illustrated in drawings or elsewhere. Similarly, any illustratedentries of the databases represent exemplary information only; one ofordinary skill in the art will understand that the number and content ofthe entries can be different from those described herein. Further,despite any depiction of the databases as tables, other formats(including relational databases, object-based models and/or distributeddatabases) could be used to store and manipulate the data typesdescribed herein. Likewise, object methods or behaviors of a databasecan be used to implement various processes, such as the describedherein. In addition, the databases may, in a known manner, be storedlocally or remotely from a device that accesses data in such a database.

The present invention can be configured to work in a network environmentincluding a computer that is in communication, via a communicationsnetwork, with one or more devices. The computer may communicate with thedevices directly or indirectly, via a wired or wireless medium such asthe Internet, LAN, WAN or Ethernet, Token Ring, or via any appropriatecommunications means or combination of communications means. Each of thedevices may comprise computers, such as those based on the Intel®Pentium® or Centrino™ processor, that are adapted to communicate withthe computer. Any number and type of machines may be in communicationwith the computer.

The present disclosure provides, to one of ordinary skill in the art, anenabling description of several embodiments and/or inventions. Some ofthese embodiments and/or inventions may not be claimed in the presentapplication, but may nevertheless be claimed in one or more continuingapplications that claim the benefit of priority of the presentapplication. Applicants intend to file additional applications to pursuepatents for subject matter that has been disclosed and enabled but notclaimed in the present application.

1. A method, comprising: identifying an occurrence of an eventassociated with the taking of a substance by a patient; determiningoutput information associated with a game; and providing the outputinformation to the patient.
 2. The method of claim 1, wherein thesubstance comprises a prescription medication.
 3. The method of claim 1,wherein the substance comprises a vitamin.
 4. The method of claim 1,wherein the substance comprises at least one of a food or a drink. 5.The method of claim 1, wherein the determining is based, at least inpart, on the identifying.
 6. The method of claim 1, further comprising:determining whether the occurrence of the event is compliant with acondition associated with the taking of the substance.
 7. The method ofclaim 6, further comprising: storing an indication of the status of thecompliance with the condition.
 8. The method of claim 7, furthercomprising: receiving an indication associated with a query of thestatus of the compliance with the condition; and providing, in responseto the query, an indication of the status of the compliance with thecondition.
 9. The method of claim 6, wherein the determining of theoutput information is based, at least in part, on the determination ofwhether the occurrence of the event is compliant with the condition. 10.The method of claim 1, further comprising: storing an indication of theoccurrence of the event.
 11. The method of claim 1, wherein theidentifying comprises: determining that a cap to a bottle containing thesubstance is opened.
 12. The method of claim 1, wherein the identifyingcomprises: determining that a bottle containing the substance is pickedup.
 13. The method of claim 12, wherein the determining that the bottleis picked up comprises: detecting, via a pressure-sensitive pad, a massof the bottle; and detecting, via the pressure-sensitive pad, a changein the detected mass of the bottle.
 14. The method of claim 1, whereinthe identifying comprises: determining that an amount of the substanceis removed from a container.
 15. The method of claim 14, wherein thedetermining that the amount of the substance is removed from thecontainer comprises: detecting, via a pressure-sensitive pad, a mass ofthe bottle; detecting, via the pressure-sensitive pad, a change in thedetected mass of the bottle; and determining a magnitude of the changein the detected mass of the bottle.
 16. The method of claim 1, whereinthe identifying comprises: determining that a seal containing thesubstance is broken.
 17. The method of claim 1, wherein the identifyingcomprises: determining that a backing of an adhesive patch containingthe substance is removed.
 18. The method of claim 1, wherein theidentifying comprises: determining that a patch containing the substanceis applied.
 19. The method of claim 18, wherein the determining that thepatch is applied comprises: receiving a signal associated with thepatch.
 20. The method of claim 19, wherein the signal is received viathe body of the patient.
 21. The method of claim 1, wherein thedetermining of the output information comprises: determining a codeindicative of the occurrence of the event; and encoding the code. 22.The method of claim 1, wherein the output information comprises aquantity of output information and wherein the determining of the outputinformation comprises: determining a frequency associated with thetaking of the substance by the patient; and determining, based on thefrequency associated with the taking of the substance, the quantity ofthe output information.
 23. The method of claim 1, wherein the outputinformation comprises at least one of: (i) a game result; (ii) a gamehint or clue; (iii) an indication of a prize; (iv) an indication of acontingent prize; (v) a bingo number; (vi) a slot machine reel symbol;(vii) a card value; (viii) a lotto number; (ix) a coordinate associatedwith game; (x) an instruction associated with a game; or (xi) a personalidentification number.
 24. The method of claim 23, wherein the outputinformation is provided as an encoded code.
 25. The method of claim 1,wherein the providing comprises: transmitting the output information toa computing device associated with the patient.
 26. The method of claim1, wherein the providing comprises: displaying the output information tothe patient.
 27. The method of claim 26, wherein the displayingcomprises: displaying the output information via a display devicecoupled to a bottle containing the substance.
 28. The method of claim26, wherein the displaying comprises: displaying the output informationvia a display device of a compliance pad associated with the substance.29. A method, comprising: receiving a code associated with a patient,wherein the code includes encoded information that is indicative of anoccurrence of an event associated with the taking of a substance by apatient; decoding the code to determine the information; determiningwhether the occurrence of the event is compliant with a conditionassociated with the taking of the substance; and providing, in the casethat compliance with the condition is determined, one or more rewards tothe patient.
 30. The method of claim 29, wherein the receivingcomprises: initiating a communication session with the patient;prompting the patient for the code, wherein the code is displayed to thepatient via a compliance device associated with the substance; andreceiving an indication of the code from the patient.
 31. The method ofclaim 29, wherein the code further includes encoded informationindicative of at least one of a patient identifier, a substanceidentifier, an insurance identifier, and a compliance pad identifier.32. The method of claim 29, further comprising: providing a compliancepad to the patient.
 33. The method of claim 32, wherein the compliancepad generates the code based on the occurrence of the event.
 34. Themethod of claim 29, further comprising: providing a compliance report tothe patient.
 35. The method of claim 29, further comprising: providing agame board to the patient.
 36. The method of claim 35, furthercomprising: receiving an indication that the patient has successfullycompleted a game associated with the game board; and awarding a prize tothe patient.
 37. The method of claim 29, wherein the one or more rewardscomprise at least one of (i) one or more lotto tickets, (ii) one or morescratch tickets, (iii) one or more lottery numbers, (iv) one or morejackpots, (v) one or more monetary awards, (vi) one or more merchandisepurchase points, (vii) one or more travel purchase points, or (viii) oneor more personal or one or more group incentives.
 38. The method ofclaim 29, wherein the patient comprises a first patient, the conditioncomprises a first condition, and the providing of the one or morerewards comprises: determining a first magnitude of complianceassociated with the first condition of the first patient's taking of thesubstance; determining a second magnitude of compliance associated witha second condition associated with a second patient; and comparing thefirst and second magnitudes of compliance.
 39. The method of claim 38,wherein the one or more rewards are based at least in part on thecomparing of the first and second magnitudes of compliance.
 40. Themethod of claim 39, wherein the one or more rewards comprise at leastone of (i) a progressive jackpot, (ii) a team reward, (iii) a groupreward, (iv) a third-party award.
 41. An apparatus, comprising: meansfor identifying the occurrence of an event associated with the taking ofa substance by a patient; means for determining output informationassociated with a game; and means for providing the output informationto the patient.
 42. An apparatus, comprising: means for receiving a codeassociated with a patient, wherein the code includes encoded informationthat is indicative of the occurrence of an event associated with thetaking of a substance by a patient; means for decoding the code todetermine the information; means for determining whether the occurrenceof the event is compliant with a condition associated with the taking ofthe substance; and means for providing, in the case that compliance withthe condition is determined, one or more rewards to the patient.
 43. Anapparatus, comprising: a memory configured to store instruction and dataindicative of the occurrence of an event associated with the taking of asubstance by a patient; and a processor operatively coupled to executethe instruction stored in the memory to: identify the occurrence of theevent associated with the taking of the substance by the patient;determine output information associated with a game; and provide theoutput information to the patient.
 44. A method comprising: recordingdata descriptive of one or more cap removal actions by a patient;encrypting the data into a code that cannot be decrypted without use ofa cryptographic decoding protocol; and outputting the code to thepatient to enable the patient to communicate the code to a system thatis operable to decrypt the code and, if the data encrypted in the codeindicates compliance with a description instruction, is operable toenter the patient into a sweepstakes upon the patient communicating thecode to the system.
 45. A method, comprising: identifying an occurrenceof an event associated with the taking of a substance by a patient;determining whether the occurrence of the event is compliant with acondition associated with the taking of the substance; determining,based at least in part on the determination of whether the occurrence ofthe event is compliant with the condition, output information associatedwith a game; and providing the output information to the patient.